Sr. Clinical Trial Manager Position Description
- The Sr. CTM serves in the role of the Clinical Trial Lead (CTL) acting as the primary operational contact for the study leading the cross-functional team for execution of the study.
- The Sr. CTM provides strategic and operational leadership to the clinical operations team to ensure project milestones deliver on time, within budget, high quality, and in compliance with the ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/Work Instructions (WIs).
- The Sr. CTM should work independently and with minimal supervision; have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the study or studies with effective communication across the organization.
- This position may include line management responsibilities.
- Accountable for quality data and meeting timelines and providing guidance to study team as needed. Oversees the review of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures.
- Models and encourages a culture of proactive and innovative goal setting, effectively articulating the vision of meaningful and measurable goals and objectives for the team; ensuring direct reports' goals are aligned to the department and corporate goals balancing buy-in across team and cross functional members while evaluating all performance aspects from study planning through execution tracking performance metrics and quality indicators
- Recognizes cross functional or company-wide impact of problems and considers implications in solution management while serving as an escalation point and resource for internal/external teams and investigational sites.
- Oversees/facilitates country and site feasibility/selection processes.
- Develops/oversees subject recruitment/retention strategy and related initiatives.
- Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and vendors
- Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
- In collaboration with clinical drug supply, ensure proper management of Investigational Product (ie, review and approve labeling, IRT set-up, IP accountability oversight, etc.)
- Ensures that all aspects of GCP compliance and inspection readiness are maintained throughout study conduct
- Participates in interim and final report preparation for regulatory submissions
- Has a strong track record of meeting commitments and delivering high quality work on time performing Sponsor quality oversight of clinical staff or CRO performance adherence to GCP, corporate SOPs and protocol as needed
- BA/BS or equivalent training and/or experience. Advance degree preferred (MA/MS, PharmD, PhD).
- 7+ years of clinical trial research management experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (with at least 1+ year at a Sponsor company is preferred).
- 3+ years of line management experience.
- Experience in interactions with outside vendors, e.g., CROs and other vendors
- Familiar with advanced concepts of clinical research and able to work effectively in a team/matrix environment.
- Ability to work on complex or multiple projects while soliciting ideas from others to form decisions and plans, fostering and recognizing mutually beneficial working relationships with people and departments to influence through formal or informal networking channels toward meeting objectives.
- Beyond having strong attention to detail and excellent organization skills should demonstrate the ability to compare and find optimum solutions, looking beyond the obvious, avoiding bias and historical crutches.
- Approaches interpersonal and communication engagements with energy, fostering active listening, carefully listening to other perspectives with respectfulness, transparency, i.e., assuring everyone has information needed to be effective and efficient and works toward conflict resolution with skillful composure and making decisions based on known facts.
- Ability to work effectively (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors, facilitating small and large meetings, promoting collaboration while accomplishing meeting objectives.
- Experience in global trials and oncology preferred.
- SharePoint experience.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.