Clinical Project Manager

Ipsen•Cambridge, MA

8d•Onsite

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! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Requirements

5+ years relevant experience in pharmaceutical drug development, including project management of US Phase I-IV studies OR significant and relevant experience in RWE/HEOR, non-interventional studies, and Investigator-Sponsored Studies (ISS).
Proven track record of delivery of projects to time, budget, and quality.
Deep 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.
Experience in working with multidisciplinary groups and ability to work within a team environment.
Experience in managing and developing relationships with Service Providers.
Excellent organizational and management skills.
Excellent verbal and written communication skills.
Experienced with Microsoft Office applications for creating and maintaining project timelines, budgets, and report.
Bachelor’s life science degree required.
Fluent in English

Nice To Haves

Extensive track record of interactions with country Medical Affairs Staff is a significant plus.
Experience in Oncology or in Rare Diseases or in Neurosciences is preferred.
Master’s degree or equivalent preferred.

Responsibilities

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.
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 the application of project management best practices.
Oversee SP performance and creation of documents required for the execution of the study.
Identify and select investigator sites in collaboration with the Medical Asset Lead, SP and MSL team.
Coordinate the set-up of the eTMF (Trial Master File).
Ensure that the study CFT and investigator sites are appropriately trained.
Complete posting of the study on external registries (clinicaltrials.gov etc.) in partnership with the Global Regulatory team to ensure compliance with Ipsen transparency requirements and regulatory commitments.
Ensure (or Oversight of) that all necessary regulatory, ethical, IRB and governance approvals are in place prior to the 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.
Proactively escalate deviations and non-compliances affecting the rights, well-being, and safety of patients, adherence to the protocol or the ethical conduct of the study.
Provide end-to-end oversight of the data to ensure delivery to a defined protocol, timelines, and quality, timely execution of data deliverables, and subsequent delivery of excellence in execution.
Provide and present regular reports on study progress, including site performance, data quality, and resource needs.
Ensure that the CTMS is updated and that data in SMD is submission ready.
Accountable for eTMF inspection readiness.
Coordinate the preparation, review, and 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.
Ensure all the close-out activities are completed per study plan and relevant SOPs.