301 Binney St.
Post Date: 05/03/2018
Job ID: 1957
Job Category: Clinical: Clinical Operations and Development
The Sr. Clinical Trial Manager (CTM) is responsible for the planning, implementation and conduct of large, global patient registries and post-marketing research studies. The Sr. CTM is expected to provide leadership within clinical operations and guidance with regards to the operational aspects of achieving clinical and medical affairs deliverables.
Primary Responsibilities Include:
Clinical Trial Management:
- Serve as the subject matter expert within clinical operations for the planning and execution of patient registries, post-marketing surveillance studies, and Phase IV clinical studies.
- Collaborate with Medical Affairs to support feasibility, concept and protocol development, and execution of registries and studies.
- Serve as the operational point person managing protocol execution, including the oversight of CROs, vendors and consultants that are involved with the registry or study.
- Responsible for oversight and clinical project management of individual studies as well as relevant program related activities.
- Understand standard practice for collecting patient-reported outcomes, post-marketing pharmacovigilance/safety data, and health economic endpoints.
- 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.
- Participate in program strategy meetings, ad hoc clinical operations’ initiatives and programs.
- Assist in preparation and review of clinical documentation such as informed consent, clinical protocols, Investigator Brochure, Clinical Monitoring Plan, Project Plan.
- 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.
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 with a focus on patient registries, post-marketing surveillance studies, and Phase IV clinical studies.
- 1-3+ years of clinical study management experience with global clinical studies, pediatric and rare disease knowledge preferred.
- Experience in management of CROs, vendors and consultants.
- Documented training, knowledge and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies.
- Experience developing trial plans including site management, risk mitigation strategies, trial budgets and program-level budgets.
- 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.
- Recognized by former peers, colleagues, managers and direct reports for attributes congruent with company Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.