Seeking a talented, experienced and highly motivated Regional Lead of Clinical Operations with a passion for new cancer therapy development. This role will be responsible for the (regional) operational execution, oversight and management of one or more clinical trials from start-up through close out for early stage clinical programs.
As a Regional Lead, you will work directly with cross-functional representatives including Medical Monitor, Clinical Science, Clinical Data Management, Regulatory, Biostatistics, Pharmacology and Translational Science and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills and play a key role in clinical trial planning and execution. As a member of our dynamic group, you will help to grow the pipeline.
What you'll do:
- Support the Study Lead and Study Execution Team (SET) to ensure trials are initiated efficiently and completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations and ICH/GCP guidelines with minimal supervision
- In collaboration with SET, develop, review and facilitate Request for Proposals (RFPs), and contribute to bid defense meetings to select Contract Research Organizations (CROs) and other clinical vendors for the right strategic fit
- Manage various clinical vendors to ensure that project and corporate goals are achieved on time and within budget
- Contribute to development and review key clinical documents (e.g., protocols, informed consent forms (ICFs), case report forms (CRFs), study reference manuals, study plans)
- Serve as subject matter expert (SME) on various company/department initiatives and participate in the development, review and implementation of departmental SOPs and processesFiscal and contracts management: oversee and manage vendor contracts, forecast financials in partnership with finance, reconcile invoices against accruals, ensure accuracy of all CRO/vendor work order and change order updates
- Participate in implementation and oversight of clinical systems including but not limited to CTMS, TMF, EDC and IRT
- Clinical data review of data listings and summary tables, including query generation
- Site management (e.g., review of monitoring reports, recruitment, quality metrics) in collaboration with CRO
- Participate in other study activities as needed (e.g., site selection, start-up, recruitment, protocol deviation and TMF review)
- Provide input and support in development and review of key study documents including protocols, ICFs, CRFs, study plans, Clinical Study Reports (CSR), as appropriate
- Review and track key study metrics and progress reports; anticipate complex obstacles and clinical trial challenges and implement creative solutions to achieve project goals and timelines
- Risk management: Proactively identify potential study risks, recommend mitigation strategies/solutions and facilitate discussions with internal and external stakeholders for implementation
- Establish and maintain strong relationships with internal cross-functional teams, CROs and vendors, and clinical research site personnel for successful execution of clinical trials
- Train investigators and site staff, vendors and team members on study protocol and trial conduct processes
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial and conduct periodic TMF reviews/QCs, as needed
- Ensure the clinical trial(s) are inspection ready at all times and participate in Quality Assurance and/or regulatory authority inspection audits, as needed
- May require occasional domestic and international travel
- Perform other duties as assigned
Requirements:
- Bachelors in life sciences or related discipline with 6+ years of experience in clinical and drug development
- Advanced knowledge of domestic and global clinical study management and vendor management experience in oncology including interpretation and implementation of FDA and ICH/GCP regulations and guidelines
- Early phase oncology trial management experience preferred including precision medicine trials
- Self-motivated and strive for continuous improvement and embrace innovative ideas in daily work
- Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships
- Detailed oriented and creative thinker with a passion for process optimization
- Excellent organizational, analytical and communication (verbal and written) skills in a fast-paced, and rapidly growing dynamic company
- Analyze and triage problems, prioritize accordingly, and propose solutions
- Ability to travel as required (approximately 20%)
Contract:
- Start Date: ASAP
- Contract Length: 12 months
- Hours: 40 hours a week
- Remote (up to 20% travel)
- W2
