IQVIA
Reading, Berkshire
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality. Responsabilities: Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents. Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time. Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations. Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met. Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues. Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites. Provide routine updates to the internal project team on study status/issues Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate. Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines. Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials Execute and/or deliver trial specific training as required Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Support study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as required May oversee the accurate, timely, and complete tracking of laboratory samples May represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs). Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies Contribute to preparation of investigator newsletters or email newsflashes. Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate Accountable for ensuring all study deliverables and milestones are met with quality and within timelines Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets Provides support/escalation point for direct reports as needed Profile: At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus Experience with start-up and initiation of clinical trial sites Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required Ability to communicate and coordinate activities with the internal team, clinical sites and vendors Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision Ability to work independently Experience presenting high level presentations, both orally and in writing Knowledge of and experience with immunotherapies and/or Oncology At least 2 years of on-site monitoring experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
The Senior Clinical Trial Manager will be responsible for managing clinical trial sites from study startup throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Sponsor Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Sponsor functional departments (as required) to drive start-up and ongoing oversight of clinical studies. They may have direct reports of Clinical Trial Managers across the clinical operations portfolios ensuring their clinical program deliverables are delivered to time, cost and quality. Responsabilities: Participate in the planning, implementation and management of sponsor clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable sponsor controlled documents. Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time. Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations. Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with sponsor CPM and sponsor Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met. Manage study start up in collaboration with internal and external project teams (e.g. sponsor Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues. Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites. Provide routine updates to the internal project team on study status/issues Manages the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection Provide direction and support to the CPM in ensuring consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate. Manages consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate Works cross-functionally with other sponsor departments (Clinical Supplies, Quality Assurance, Regulatory Affairs) to ensure all clinical trial activities performed by sponsor as a Sponsor are performed according to study requirements and timelines. Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, protocol, informed consent documents (master and/or site specific), budgets, monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals, case report form development and training materials Execute and/or deliver trial specific training as required Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies Contribute to the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Support study team with site selection while optimizing start-up processes to ensure efficient start-up timelines are met. Attend and present at Investigator Meetings on Clinical Operations topics, as required May oversee the accurate, timely, and complete tracking of laboratory samples May represent Clinical Operations in cross-functional initiatives (e.g., start-up, continued process improvements with CROs). Contribute to the development and/or participate in the review of sponsor SOPs, Work Instructions and team policies Contribute to preparation of investigator newsletters or email newsflashes. Supports the internal and external project teams with audits/inspection readiness and activities, resolution of audit/inspection findings and contribution to CAPAs as required Oversight of direct report(s) study execution and procedures as required to ensure regulatory compliance of protocol activities, if appropriate Accountable for ensuring all study deliverables and milestones are met with quality and within timelines Provide direction and support to direct report(s) to ensure consistent approach and process to study execution and procedures amongst various program assets Provides support/escalation point for direct reports as needed Profile: At least 8 years of relevant clinical operational experience in a biotechnology/pharmaceutical company, and/or CRO Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus Experience with start-up and initiation of clinical trial sites Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required Ability to communicate and coordinate activities with the internal team, clinical sites and vendors Proactively identify project challenges/risks and appropriate corrective actions to the internal study teams and work with internal team, clinical sites and vendors on resolutions with minimal supervision Ability to work independently Experience presenting high level presentations, both orally and in writing Knowledge of and experience with immunotherapies and/or Oncology At least 2 years of on-site monitoring experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
IQVIA
Real World Commercial Solutions to Create a Healthier World In RWCS we're passionate about improving the life sciences ecosystem and making decisions that accelerate innovation for a healthier world. Every day our team develops evidence-based strategies that are used in published research, clinical guidelines, and market access decisions, to improve healthcare at every touchpoint. We design and deliver Commercial Analytics, supported by our world-class proprietary data assets, solve complex client challenges through strategic consulting, and use leading edge market research techniques to support clients brand strategy, planning and measurement. We're purpose-driven problem solvers, that do what we love to make a greater impact on human health. Integrated Research We focus on understanding the behaviours and attitudes of Health Care Professionals and patients, and supporting international pharmaceutical companies to understand them as people. This is across the product lifecycle. We explore and measure what Health Care Professionals and patients say and do using different behavioural frameworks to deliver actionable insights and clear answers to our clients' business questions. We typically use IQVIA data to contextualise our research and collaborate with other IQVIA teams to provide our clients with comprehensive solutions to their business issues. The Role The Engagement Manager role in our EMEA Integrated Research team is critical for driving innovative solutions to key HQ clients based in EMEA. It is expected that the post holder will assist generating target revenues and will work with clients to provide strategic support to answer business issues, oversee the delivery of high-quality studies and generate repeat business. The post holder will focus on integrating different research solutions, such as primary and secondary intelligence, and employing the broader IQVIA offer to have meaningful discussions with clients. The Engagement Manager would be responsible for developing winning proposals for clients, evaluating and proposing different methodological solutions to the client. They also play a key role in coaching the team and supporting the developing of up and coming talent. The candidate will therefore be excited about developing new solutions and services, driving business development activities and delivering projects of the highest quality by working across different geographies. What You'll Be Doing Leading the delivery of the IR offer for key HQ clients in EMEA, deploying the right delivery resources and innovation to ensure repeat and new business is generated from major accounts Understanding clients' needs and developing high quality proposals to address those Bringing strategic thinking to client issues, developing clear actions for the client to solve their issues and acting as the trusted advisor to clients on a project basis Ensuring that offering development is scalable across different client business issues Design research solutions, including identification of relevant data assets, methodology, samples, questionnaires, discussion guides and other research tools Taking a leadership role in implementing B&IRS business vision and objectives, and support the development of the business Coaching offshore team and more junior team members Taking responsibility for a significant part of the business, achieving revenue targets Managing end to end consulting and Primary Market Research projects including coordination of multidisciplinary teams staffed to the project, such as fieldwork, programming and desk research Who You Are A university degree holder with 8+ years of experience in life science or healthcare consulting. Preferential consideration will be given to candidates with experience in carrying out consulting and market research projects in the pharmaceutical area at an international/cross-country level. Able to demonstrate excellent project management, relationship-building, and client-influencing skills with an established network and referral contacts. Strong capability in managing large and/or multiple projects and juggling priorities so that deadlines are met while retaining consistently high-quality outcomes. Ability to contribute to business development through the identification of leads, development of proposals etc. Excellent knowledge of English and of the main Microsoft Office tools (Word, Excel, Powerpoint). Benefits We work hard to prioritise the things that matter most to you. Visit our benefits page for information on everything from perks to well-being initiatives and career enhancement. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Real World Commercial Solutions to Create a Healthier World In RWCS we're passionate about improving the life sciences ecosystem and making decisions that accelerate innovation for a healthier world. Every day our team develops evidence-based strategies that are used in published research, clinical guidelines, and market access decisions, to improve healthcare at every touchpoint. We design and deliver Commercial Analytics, supported by our world-class proprietary data assets, solve complex client challenges through strategic consulting, and use leading edge market research techniques to support clients brand strategy, planning and measurement. We're purpose-driven problem solvers, that do what we love to make a greater impact on human health. Integrated Research We focus on understanding the behaviours and attitudes of Health Care Professionals and patients, and supporting international pharmaceutical companies to understand them as people. This is across the product lifecycle. We explore and measure what Health Care Professionals and patients say and do using different behavioural frameworks to deliver actionable insights and clear answers to our clients' business questions. We typically use IQVIA data to contextualise our research and collaborate with other IQVIA teams to provide our clients with comprehensive solutions to their business issues. The Role The Engagement Manager role in our EMEA Integrated Research team is critical for driving innovative solutions to key HQ clients based in EMEA. It is expected that the post holder will assist generating target revenues and will work with clients to provide strategic support to answer business issues, oversee the delivery of high-quality studies and generate repeat business. The post holder will focus on integrating different research solutions, such as primary and secondary intelligence, and employing the broader IQVIA offer to have meaningful discussions with clients. The Engagement Manager would be responsible for developing winning proposals for clients, evaluating and proposing different methodological solutions to the client. They also play a key role in coaching the team and supporting the developing of up and coming talent. The candidate will therefore be excited about developing new solutions and services, driving business development activities and delivering projects of the highest quality by working across different geographies. What You'll Be Doing Leading the delivery of the IR offer for key HQ clients in EMEA, deploying the right delivery resources and innovation to ensure repeat and new business is generated from major accounts Understanding clients' needs and developing high quality proposals to address those Bringing strategic thinking to client issues, developing clear actions for the client to solve their issues and acting as the trusted advisor to clients on a project basis Ensuring that offering development is scalable across different client business issues Design research solutions, including identification of relevant data assets, methodology, samples, questionnaires, discussion guides and other research tools Taking a leadership role in implementing B&IRS business vision and objectives, and support the development of the business Coaching offshore team and more junior team members Taking responsibility for a significant part of the business, achieving revenue targets Managing end to end consulting and Primary Market Research projects including coordination of multidisciplinary teams staffed to the project, such as fieldwork, programming and desk research Who You Are A university degree holder with 8+ years of experience in life science or healthcare consulting. Preferential consideration will be given to candidates with experience in carrying out consulting and market research projects in the pharmaceutical area at an international/cross-country level. Able to demonstrate excellent project management, relationship-building, and client-influencing skills with an established network and referral contacts. Strong capability in managing large and/or multiple projects and juggling priorities so that deadlines are met while retaining consistently high-quality outcomes. Ability to contribute to business development through the identification of leads, development of proposals etc. Excellent knowledge of English and of the main Microsoft Office tools (Word, Excel, Powerpoint). Benefits We work hard to prioritise the things that matter most to you. Visit our benefits page for information on everything from perks to well-being initiatives and career enhancement. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
IQVIA
Real World Commercial Solutions to Create a Healthier World In RWCS we're passionate about improving the life sciences ecosystem and making decisions that accelerate innovation for a healthier world. Every day our team develops evidence-based strategies that are used in published research, clinical guidelines, and market access decisions, to improve healthcare at every touchpoint. We design and deliver Commercial Analytics, supported by our world-class proprietary data assets, solve complex client challenges through strategic consulting, and use leading edge market research techniques to support clients brand strategy, planning and measurement. We're purpose-driven problem solvers, that do what we love to make a greater impact on human health. Integrated Research We focus on understanding the behaviours and attitudes of Health Care Professionals and patients, and supporting international pharmaceutical companies to understand them as people. This is across the product lifecycle. We explore and measure what Health Care Professionals and patients say and do using different behavioural frameworks to deliver actionable insights and clear answers to our clients' business questions. We typically use IQVIA data to contextualise our research and collaborate with other IQVIA teams to provide our clients with comprehensive solutions to their business issues. The Role The Engagement Manager role in our EMEA Integrated Research team is critical for driving innovative solutions to key HQ clients based in EMEA. It is expected that the post holder will assist generating target revenues and will work with clients to provide strategic support to answer business issues, oversee the delivery of high-quality studies and generate repeat business. The post holder will focus on integrating different research solutions, such as primary and secondary intelligence, and employing the broader IQVIA offer to have meaningful discussions with clients. The Engagement Manager would be responsible for developing winning proposals for clients, evaluating and proposing different methodological solutions to the client. They also play a key role in coaching the team and supporting the developing of up and coming talent. The candidate will therefore be excited about developing new solutions and services, driving business development activities and delivering projects of the highest quality by working across different geographies. What You'll Be Doing Leading the delivery of the IR offer for key HQ clients in EMEA, deploying the right delivery resources and innovation to ensure repeat and new business is generated from major accounts Understanding clients' needs and developing high quality proposals to address those Bringing strategic thinking to client issues, developing clear actions for the client to solve their issues and acting as the trusted advisor to clients on a project basis Ensuring that offering development is scalable across different client business issues Design research solutions, including identification of relevant data assets, methodology, samples, questionnaires, discussion guides and other research tools Taking a leadership role in implementing B&IRS business vision and objectives, and support the development of the business Coaching offshore team and more junior team members Taking responsibility for a significant part of the business, achieving revenue targets Managing end to end consulting and Primary Market Research projects including coordination of multidisciplinary teams staffed to the project, such as fieldwork, programming and desk research Who You Are A university degree holder with 8+ years of experience in life science or healthcare consulting. Preferential consideration will be given to candidates with experience in carrying out consulting and market research projects in the pharmaceutical area at an international/cross-country level. Able to demonstrate excellent project management, relationship-building, and client-influencing skills with an established network and referral contacts. Strong capability in managing large and/or multiple projects and juggling priorities so that deadlines are met while retaining consistently high-quality outcomes. Ability to contribute to business development through the identification of leads, development of proposals etc. Excellent knowledge of English and of the main Microsoft Office tools (Word, Excel, Powerpoint). Benefits We work hard to prioritise the things that matter most to you. Visit our benefits page for information on everything from perks to well-being initiatives and career enhancement. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
Real World Commercial Solutions to Create a Healthier World In RWCS we're passionate about improving the life sciences ecosystem and making decisions that accelerate innovation for a healthier world. Every day our team develops evidence-based strategies that are used in published research, clinical guidelines, and market access decisions, to improve healthcare at every touchpoint. We design and deliver Commercial Analytics, supported by our world-class proprietary data assets, solve complex client challenges through strategic consulting, and use leading edge market research techniques to support clients brand strategy, planning and measurement. We're purpose-driven problem solvers, that do what we love to make a greater impact on human health. Integrated Research We focus on understanding the behaviours and attitudes of Health Care Professionals and patients, and supporting international pharmaceutical companies to understand them as people. This is across the product lifecycle. We explore and measure what Health Care Professionals and patients say and do using different behavioural frameworks to deliver actionable insights and clear answers to our clients' business questions. We typically use IQVIA data to contextualise our research and collaborate with other IQVIA teams to provide our clients with comprehensive solutions to their business issues. The Role The Engagement Manager role in our EMEA Integrated Research team is critical for driving innovative solutions to key HQ clients based in EMEA. It is expected that the post holder will assist generating target revenues and will work with clients to provide strategic support to answer business issues, oversee the delivery of high-quality studies and generate repeat business. The post holder will focus on integrating different research solutions, such as primary and secondary intelligence, and employing the broader IQVIA offer to have meaningful discussions with clients. The Engagement Manager would be responsible for developing winning proposals for clients, evaluating and proposing different methodological solutions to the client. They also play a key role in coaching the team and supporting the developing of up and coming talent. The candidate will therefore be excited about developing new solutions and services, driving business development activities and delivering projects of the highest quality by working across different geographies. What You'll Be Doing Leading the delivery of the IR offer for key HQ clients in EMEA, deploying the right delivery resources and innovation to ensure repeat and new business is generated from major accounts Understanding clients' needs and developing high quality proposals to address those Bringing strategic thinking to client issues, developing clear actions for the client to solve their issues and acting as the trusted advisor to clients on a project basis Ensuring that offering development is scalable across different client business issues Design research solutions, including identification of relevant data assets, methodology, samples, questionnaires, discussion guides and other research tools Taking a leadership role in implementing B&IRS business vision and objectives, and support the development of the business Coaching offshore team and more junior team members Taking responsibility for a significant part of the business, achieving revenue targets Managing end to end consulting and Primary Market Research projects including coordination of multidisciplinary teams staffed to the project, such as fieldwork, programming and desk research Who You Are A university degree holder with 8+ years of experience in life science or healthcare consulting. Preferential consideration will be given to candidates with experience in carrying out consulting and market research projects in the pharmaceutical area at an international/cross-country level. Able to demonstrate excellent project management, relationship-building, and client-influencing skills with an established network and referral contacts. Strong capability in managing large and/or multiple projects and juggling priorities so that deadlines are met while retaining consistently high-quality outcomes. Ability to contribute to business development through the identification of leads, development of proposals etc. Excellent knowledge of English and of the main Microsoft Office tools (Word, Excel, Powerpoint). Benefits We work hard to prioritise the things that matter most to you. Visit our benefits page for information on everything from perks to well-being initiatives and career enhancement. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at
