Clinical Project Manager

Title:

Clinical Project Manager

Company:

Ipsen Biopharmaceuticals Inc.

 

About Ipsen:

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.

Job Description:

WHAT - Main Responsibilities & Technical Competencies

Company Sponsored Studies (CSS)

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.
• 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.

Initiation of the study

• 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. (e.g.: Oversight of or creation and approval of investigator training materials, completion and co-ordination of investigator’s meetings)
• 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.

Study Conduct

• 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.

Study Completion

• 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.

HOW - Knowledge & Experience

Knowledge & Experience (essential):

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

Knowledge & Experience (preferred):

•  Experience in Oncology or in Rare Diseases or in Neurosciences is preferred

Education / Certifications (essential):

• Bachelor’s life science degree required.
• Master’s degree or equivalent preferred.

Language(s) (essential):

• Fluent in English

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.  The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The annual base salary range for this position is $112,500-$165,000.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.