Sr. Clinical Trial Manager
The Sr. Clinical Trial Manager (CTM) is responsible for the planning, implementation and conduct of large, global, complex clinical trials in Phase 1-3; or multiple smaller early-phase studies. The Sr. CTM is expected to provide leadership within the department and guidance with regards to the operational aspects of executing clinical development deliverables. This position reports to the Director, Clinical Operations.
Primary Responsibilities Include:
Clinical Trial Management
- Serve as the clinical point person managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the clinical trial and program.
- Lead and coordinate clinical study management meetings
- Responsible for oversight and project management of individual studies as well as relevant program related activities.
- Train team members and site staff, including vendors, as needed
- Drive traceability procedures for investigational products and cross functionally coordinate patient treatment planning
- Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, and motivational visits, as needed
- Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines.
- Ensure trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs.
- Assist in preparation and review of clinical documentation such as informed consent, clinical protocols, Investigator Brochure, Clinical Monitoring Plan, study manuals, study tools, etc.
- Assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports.
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews.
- Participate and respond to Quality Assurance and/or regulatory authority inspection audits.
Fiscal and Contracts Management
- Participate in request and review of scope of work, budgets, vendor performance and issue resolution.
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents.
- Manage clinical trial budgets, providing ongoing financial reporting and projections to finance group.
- Responsible for creation and management of program-level budget(s) with Program Lead.
- Participate in contract and budget negotiations with CROs, clinical sites and vendors
Cross Functional Mentoring and Leadership
- Work cross-functionally to ensure clinical program timelines and goals are met.
- Provide study-specific mentoring and line management for junior team members, as appropriate.
- Assume leadership role in operational improvement initiatives (e.g. SOP development, training etc.).
Education and Skills Requirements:
- Bachelor’s degree in health sciences or related field.
- Minimum of 7+ years’ experience in clinical research with at least 5 years’ experience in study management.
- 1-3+ years of clinical study management experience with global clinical studies.
- Experience in management of CROs, vendors and consultants.
- Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials.
- Experience developing trial plans including site monitoring, risk mitigation strategies, trial budgets and program-level budgets, site selection and clinical supplies management.
- Proficient written and verbal communication skills.
- Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Position may require some travel.
- Ability to thrive in a fast-paced, entrepreneurial environment with busy, high performing colleagues
- Ability to function at a high level in a team setting
- Proactive and positive management approach
- Maximum flexibility to adapt to changing program needs in real time
- Strong leadership skills
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with CPI FIRST Values: Focus, Integrity, Respect, Science, Teaching
- Excitement about the vision and mission of CPI
JOB CODE: SCTM
Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.