Senior Clinical Project Manager

Ipsen•Cambridge, MA

10d

About The Position

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! Clinical Research Leadership (Senior Clinical Project Manager) To work with internal stakeholders and Cross Functional Team to ensure excellence in execution of all evidence generation activities. To provide internal consultancy and thought leadership with regards to the conduct of clinical research To contribute to, and provide insight on, the design and development of study synopses and research protocols aligned with Integrated Evidence Generation Plans (IEGP), to ensure they are operationally viable, in order to support the study through Ipsen approval pathways. To participate in consultations with key opinion leaders and external stakeholders, to develop studies relevant to patients and the clinical community. Preparation of the study Set-up and lead the study Cross Functional Team (CFT) overseeing study design and kick-off activities. Initiate high level feasibility and continuously monitor how changes to the study design affect feasibility during the preparation and development of the study protocol. Own preparation of the project budget including financial and clinical supply forecasting. Develop the study timelines planning for critical events and milestones as agreed by the Cross Functional Team. Drive excellence in execution and adherence to the project plan through application of project management best practices. Liaise with Global Patients Affairs to embed patient centricity into study conduct and the design of Ipsen evidence generation activities. Maintain awareness of digital opportunities through collaborative work with the Data & Insights Generation and Strategy (DIGS) and data strategy teams Establish close working relationships with Lead Medical Experts, Global Regulatory Affairs and Global Pharmacovigilance to support the submission and approval of PASS/PAES protocols to regulatory bodies such as EMA’s PRAC, the FDA, regional and local regulatory authorities. Initiation of the study Lead the SP selection process (RFP creation, bid defense, contracting) and in collaboration with the CFT, Global Procurement and Corporate Legal Affairs. Co-ordinate completion of the study document and plans, defining and agreeing KPIs/QTLs/Performance indicators with SPs and the Cross Functional Team. Oversee SP performance and creation of relevant SP documents, required for the execution of the study. Identify and select investigator sites in collaboration with the Medical Asset Lead, SP and Ipsen Affiliates. Coordinate the set-up of the eTMF (Trial Master File) in collaboration with the CTA assigned to the study. Ensure that the study CFT and investigator sites are appropriately trained. (e.g.: Oversight of or creation and approval of investigator training materials, completion and co-ordination of investigator’s meetings). Ensure posting of the study on external registries (clinicaltrials.gov etc.) in compliance with Ipsen transparency requirements and regulatory commitments. Ensure (or oversight of) all necessary regulatory, ethical, IRB and governance approvals are in place prior to commencement of recruitment at an investigator site. Study Conduct Coordinate the CFT (internal and SPs), overseeing the progress of the study and SP’s performance to ensure timely on budget delivery. Monitor execution and delivery of KPIs/QTLs/Performance indicators as agreed in the IOP. If applicable for projects assigned, review site visit reports per the IOP, ensuring timely and appropriate follow up of issues raised by monitors, cross functional team members, affiliates and/or CROs as appropriate. If applicable liaise with Regional Clinical Operations team to execute any co-monitoring activities defined for SP oversight and/or set up regular meetings with MSLs (Medical Science Liaison) at LMA (Local Medical Affairs) who may be able to support Clinical Operations at various steps (site qualification, site recruitment). Proactively escalate deviations and non-compliances affecting the rights, wellbeing and safety of patients, adherence to the protocol or the ethical conduct of the study. Via leadership of the study team, provide end to end oversight of the data, to ensure delivery to defined protocol, timelines and quality, timely execution of data deliverables and subsequent delivery of excellence in execution. Recommend, review and oversee amendments to study protocol ensuring implementation at investigator sites following receipt of the necessary approvals. Provide and present regular reports on study progress including site performance, data quality and resource needs. Undertake activities to inform and motivate investigators and the study team through appropriate engagement activities e.g. distribution of regular newsletters, ad hoc investigator meetings and motivational calls. Ensure that the CTMS is updated and that data in Study Master Data (SMD) is submission ready. Accountable for eTMF inspection readiness. Study Completion Coordinate the preparation, the review and the submission of the CSR with Medical Writing. Ensure the finalization and archiving of the eTMF. Ensure that the study results are posted to the required registries. All necessary regulatory reporting requirements of the study results and end of study summaries are completed.

Requirements

Significant and relevant experience of pharmaceutical drug development (Ph2, Ph3) including project management of national and international programs OR significant and relevant experience in RWE/HEOR, NIS studies, including project management of national and international programs.
Experience and know-how in Oncology or in Rare Diseases or in Neurosciences.
Proven track record of delivery of projects to time, budget and quality.
Intimate knowledge of Good Clinical Practice (GCP) for CPMs managing interventional CSS and non-GCP data regeneration regulations for CPMs managing NIS and research with SUD.
Recent, significant and successful experience in mentoring people.
Experience of working with multidisciplinary groups and ability to work within a team environment.
Experience of managing and developing relationships with Service Providers.
Excellent organisational and management skills.
Excellent verbal and written communication skills.
Computer literacy.
Ability to travel as required with the needs of the role, up to approximately 25% of the time.
Bachelor’s life science degree or Master’s degree or equivalent.
Excellent oral and written English.

Nice To Haves

Extensive track-record of interactions with country Medical Affairs Staff is a significant plus.

Responsibilities

Work with internal stakeholders and Cross Functional Team to ensure excellence in execution of all evidence generation activities.
Provide internal consultancy and thought leadership with regards to the conduct of clinical research
Contribute to, and provide insight on, the design and development of study synopses and research protocols aligned with Integrated Evidence Generation Plans (IEGP), to ensure they are operationally viable, in order to support the study through Ipsen approval pathways.
Participate in consultations with key opinion leaders and external stakeholders, to develop studies relevant to patients and the clinical community.
Set-up and lead the study Cross Functional Team (CFT) overseeing study design and kick-off activities.
Initiate high level feasibility and continuously monitor how changes to the study design affect feasibility during the preparation and development of the study protocol.
Own preparation of the project budget including financial and clinical supply forecasting.
Develop the study timelines planning for critical events and milestones as agreed by the Cross Functional Team.
Drive excellence in execution and adherence to the project plan through application of project management best practices.
Liaise with Global Patients Affairs to embed patient centricity into study conduct and the design of Ipsen evidence generation activities.
Maintain awareness of digital opportunities through collaborative work with the Data & Insights Generation and Strategy (DIGS) and data strategy teams
Establish close working relationships with Lead Medical Experts, Global Regulatory Affairs and Global Pharmacovigilance to support the submission and approval of PASS/PAES protocols to regulatory bodies such as EMA’s PRAC, the FDA, regional and local regulatory authorities.
Lead the SP selection process (RFP creation, bid defense, contracting) and in collaboration with the CFT, Global Procurement and Corporate Legal Affairs.
Co-ordinate completion of the study document and plans, defining and agreeing KPIs/QTLs/Performance indicators with SPs and the Cross Functional Team.
Oversee SP performance and creation of relevant SP documents, required for the execution of the study.
Identify and select investigator sites in collaboration with the Medical Asset Lead, SP and Ipsen Affiliates.
Coordinate the set-up of the eTMF (Trial Master File) in collaboration with the CTA assigned to the study.
Ensure that the study CFT and investigator sites are appropriately trained. (e.g.: Oversight of or creation and approval of investigator training materials, completion and co-ordination of investigator’s meetings).
Ensure posting of the study on external registries (clinicaltrials.gov etc.) in compliance with Ipsen transparency requirements and regulatory commitments.
Ensure (or oversight of) all necessary regulatory, ethical, IRB and governance approvals are in place prior to commencement of recruitment at an investigator site.
Coordinate the CFT (internal and SPs), overseeing the progress of the study and SP’s performance to ensure timely on budget delivery.
Monitor execution and delivery of KPIs/QTLs/Performance indicators as agreed in the IOP.
If applicable for projects assigned, review site visit reports per the IOP, ensuring timely and appropriate follow up of issues raised by monitors, cross functional team members, affiliates and/or CROs as appropriate.
If applicable liaise with Regional Clinical Operations team to execute any co-monitoring activities defined for SP oversight and/or set up regular meetings with MSLs (Medical Science Liaison) at LMA (Local Medical Affairs) who may be able to support Clinical Operations at various steps (site qualification, site recruitment).
Proactively escalate deviations and non-compliances affecting the rights, wellbeing and safety of patients, adherence to the protocol or the ethical conduct of the study.
Via leadership of the study team, provide end to end oversight of the data, to ensure delivery to defined protocol, timelines and quality, timely execution of data deliverables and subsequent delivery of excellence in execution.
Recommend, review and oversee amendments to study protocol ensuring implementation at investigator sites following receipt of the necessary approvals.
Provide and present regular reports on study progress including site performance, data quality and resource needs.
Undertake activities to inform and motivate investigators and the study team through appropriate engagement activities e.g. distribution of regular newsletters, ad hoc investigator meetings and motivational calls.
Ensure that the CTMS is updated and that data in Study Master Data (SMD) is submission ready.
Accountable for eTMF inspection readiness.
Coordinate the preparation, the review and the submission of the CSR with Medical Writing.
Ensure the finalization and archiving of the eTMF.
Ensure that the study results are posted to the required registries.
All necessary regulatory reporting requirements of the study results and end of study summaries are completed.