The Company
My client is a biopharmaceutical company based in Massachusetts. Their research focuses on the treatment for rare and ultra-rare diseases with a specific focus on debilitating genetic diseases. They have an opportunity for a Clinical Project Manager to join their team!
Role Summary:
The Clinical Project Manager (CPM) is responsible for providing support to one or more Study Management Teams (SMTs). The CPM is responsible for the day-to-day management of one or more clinical trial(s) and oversight of vendors, clinical monitors and clinical trial sites. The CPM is also accountable for ensuring high quality deliverables are within timelines and budget.
Responsibilities
The core duties and responsibilities of the CPM include, but are not limited to:
- Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, oversight of clinical sites, etc.
- Conduct protocol and site feasibility assessments
- Participate in the selection of vendors, including CRO, IVRS, central lab, imaging vendor, etc.
- Review draft protocols/protocol amendments and provide feedback on behalf of Clinical Operations
- Serve as a liaison and resource for clinical sites
- Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, CRF Completion Guidelines, etc.)
- Review clinical site documents (e.g., site specific informed consent forms), contracts, and payments
- Develop and maintain study timelines and enrollment dashboards
- Responsible for managing assigned vendors (e.g., CRO, Labs, etc), associated budgets and timelines
- Support the study budgeting process, including the review of clinical trial financial accruals
- Oversee the creation and maintenance of the Trial Master File
- Perform site initiation, routine monitoring and close-out visits at a limited number of clinical sites, as well as co-monitoring with Clinical Research Associates (CRAs)
- Participate in initiatives and/or special projects, as assigned
- Develop and review Standard Operating Procedures and Site Risk Management plan
- Mentor Clinical Operations staff (e.g., Clinical Trial Specialists and Clinical Trial Associates)
- May be responsible for the following activities:
- Review site visit reports
- Provide drug supply assumptions to the clinical planning team
- Facilitate CRO/vendor selection process for assigned vendors
- Training & monitoring for CRO/vendor (Kick-off meeting)
- Prepare updates for management
- Leading cross functional study management team meetings, including obtaining agreement on project timelines, study objectives and goals
Requirements
- Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
- 5+ Years experience managing the day-to-day operations of clinical trials
- Working knowledge of ICH Good Clinical Practice guidelines
- Experience with international trials is preferred
- Excellent planning and organizational skills
- Able to handle multiple tasks and deadlines
- Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
- Highly effective verbal and written communication skills
- Flexible and solution focused
- Strong patient/customer focus
- Must have the ability to build and maintain positive relationships with management, peers and clinical sites
- Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
- 10-30% travel may be required
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything