Job Code: USCD11
Position: Senior Clinical Trials Manager
Department: Clinical Development
Reports to: Executive Director, Clinical Development
Location: Bay Area, California
Connect Biopharma is a global, clinical-stage biopharmaceutical company founded by a team with broad knowledge of the drug discovery industry and expertise in targeting immunological pathways. The Senior Clinical Trials Manager provides strategic and operational leadership of clinical research studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines. Responsibilities may include operational direction of one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams.
- Will involve a combination of execution and oversight to ensure deliverables and may include, but are not limited to, the following essential functions of the job:
- Provide Sponsor oversight of study execution utilizing available performance metrics and quality indicators
- Maintenance/updating of data as appropriate in project management tools including CTMS and/or MSProject
- Sponsor oversight of clinical monitoring quality and adherence to established processes and plans
- Development, management, maintenance of study deliverables [i.e. timelines, study plans, etc.] through collaboration with internal and external stakeholders
- Proactive identification of potential risks and development/implementation of actions to avoid or mitigate
- Informing operational program lead/s and other leadership (as appropriate) on overall clinical trial plans, updated forecasting, and of potential issues/mitigation
Study Planning and Conduct
- Sponsor oversight of country and site feasibility/selection processes in collaboration with CROs
- Operational input into study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Execution Plans, Clinical Data Review Plan, Clinical Database edit specifications, Clinical Study Report (CSR) development, etc.
- Sponsor oversight of investigational product [IP]supply forecasting/management and study-level IP reconciliation in collaboration with internal CMC and external IMP management services.
- Review of the subject recruitment/retention strategy and related initiatives in collaboration with CROs
- Participation in clinical service provider (vendor) selection, specification development, and management/oversight
- Oversight of TMF set-up, ongoing quality review, and final reconciliation of study documents including review of site regulatory documents/packages and obtaining of appropriate country/site insurance
- Development/coordination of study training for study team, investigational sites, and vendors
- Oversight of required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC approvals/notifications
- Participation in Serious Adverse Event (SAE)reconciliation process
- Drive activities for efficient data cleaning and database closure.
- Ensure appropriate close out activities for sites and vendors
- Able to handle multiple projects at one time.
- Development/maintenance of collaborative relationships with internal and external partners/stakeholders
- Maintain positive relationships and aid in arranging company meetings with Key Opinion Leaders and principal investigators from Connect studies
- If required, be able to assist with presentations to Regulatory Authorities
Financial Planning and Management
- Ensure proper reconciliation of overall study budget(s)
- Review and contribute to vendor scope of work (SOW) per contract, quality, and budget
- Aid Finance in review/approval of vendor invoices and management of accruals and SOW changes
Education: Minimum of a BA/BS degree or equivalent and extensive experience in pharmaceutical development. Preferred a MA/MS plus 5-10 years’ experience in a significant clinical operations management role.
- Flexibility in adapting/reacting to changing company priorities and competitive or operational challenges
- Excellent planning and organizational skills
- Ability to interface with global clinical development teams and foster a collaborative and mutually supportive culture
- Leadership and initiative to develop clinical operations teams
- High sense of urgency and commitment to excellence in the successful achievement of objectives.
- The ability to perform in a fast-paced environment and be willing to take on additional challenges, willingness to stretch beyond and learn new skills to help the project team
- Clinical trial project management skills.
- Financial budgeting and forecasting skills.
- Leadership / influence management skills.
- In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
- Ability to effectively lead a global cross-functional team in a matrix environment.
- Time management skills – ability to effectively multi-task and prioritize.
- Proven problem solving and decision-making skills.
- Demonstrated success in using oral and written communication skills to influence, inform, or guide others
- Disease / therapeutic knowledge – At least 3 years’ experience with immunology
- Early development experience in atopic dermatitis, asthma, chronic rhinitis or inflammatory bowel disease highly preferred
- Solid computer skills – requirement of MS applications including (but not limited to) MS Project, Word, Excel
- Study Tools including electronic system skills – CTMS / EDC.
Expected Travel Time: up to 20% (but this will be curtailed until travel patterns normalize after COVID-19 pandemic)