Description
To complement our clinical team developing medicines based on the J-Brain Cargo® Technology, we are looking for an experienced clinical trial manager to join us at our location in San Diego, CA. A detailed description of the position can be found below. We are very much looking forward to hearing from individuals who believe they meet the requirements associated with the position and are looking for a greater sense of purpose in their work. For further questions or inquiries, please contact christina@humanresourceplus.com
Position Details:
Role: Sr. (International) Clinical Trial Manager
Location:
San Diego, CA (may consider regionally based/ remote, Pacific time zone hours under special circumstances)
Term: FTE; permanent
Job Description:
Position Title: Senior Clinical Trial Manager
Department: International Clinical Operations
Reports to (Position Title): Associate Director, International Clinical Operations, located in San Diego, CA.
OBJECTIVES:
• Oversee study operational execution and support planning of clinical studies for assigned clinical program(s).
• Support overall clinical trial strategy in close collaboration with the Associate Director of Clinical Operations or Clinical Operations Program Lead(s), and CRO partners as applicable.
• Ensure compliance with quality standards (including ICH GCP, local regulations, and internal or CRO’s SOPs), and trial execution on schedule and on budget.
• Interact with partners and/or other CROs and other 3rd party vendors and provide oversight to meet trial obligations described in ICH-GCP and other business objectives.
• The assigned clinical studies may be of high complexity and require high attention to detail related to multiple indications, data safety monitoring boards and/or endpoint review committees, interim analyses, etc.
• Multiple vendor oversight responsibilities, and more than one study and/or more than one indication may be assigned.
RESPONSIBILITIES:
• Operational execution of assigned clinical trials.
• Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.
• Guide and challenge study team to ensure operational feasibility, inclusive of patient and site burden.
• Validate budget and ensure impacts are adequately addressed.
• Participate in country and site feasibility/selection process to ensure alignment between study operations and program strategy.
• Ensure study timelines are met.
• Ensure new team members and vendors are appropriately onboarded.
• Provide oversight/support/guidance to strategic partners/CROs to ensure study issues are addressed and resolved rapidly.
• Contribute to risk assessment and establishment of risk management plans.
• Support study budget planning and management and reviewing external spend related to study execution. Works closely with International Clinical Operations Program Leader(s).
• Communicate study status, cost, and issues to International Clinical Operations Program Lead(s) and at internal meetings; serves as escalation point for third party vendors including those managed by strategic partners and/or other CROs.
• Oversee strategic partners/CROs/, supports vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
• Ensure quality standards are met in all clinical trials, including, and not limited to review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring.
• Review and endorsement of relevant study plans. As applicable: Study team meeting management and attendance, when necessary, regular review of meeting agendas and minutes.
• Review of outcomes/actions related to protocol deviations.
• Document review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies.
• In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
• Ensure studies are “inspection ready” according to ICH GCP standards.
• Represent the International Clinical Trial Manager role in functional initiatives or working groups.
• Help with onboarding and mentoring of new or junior clinical operations members.
• May assist the program leader(s) in his/her/they role, as required.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education: Bachelor’s Degree or international equivalent required; Life Sciences highly preferred.
Skills:
• Knowledge of global regulatory guidelines and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
• Demonstrated excellence in trial management and execution.
• Excellent communication skills.
• Excellent teamwork, organizational, interpersonal, and problem-solving skills.
• Fluent business English (oral and written).
• Proficient in common software (MS Office) and clinical trial software.
Experience:
• 6+ years’ experience in pharmaceutical industry and/or clinical research organization, including 4+ years clinical study management/oversight.
• Experience in rare diseases is advantageous.
• Advanced degree(s) (e.g., Master or Doctorate) and relevant training or experience (e.g., fellowship. internships, etc.) will be considered to supplement experience requirements.
TRAVEL REQUIREMENTS and Time zone flexibility:
• Requires approximately 5-25 % travel, including overnight and international travel to other Clients sites, strategic partners, and therapeutic area required travel.
• Ability to work across global time zones to address the needs of International global trials and to join videoconferences with Asia/Pacific, Europe, and South American colleagues and vendors.
