Clinical Trial Manager – ISS Operations - United States
Compliance with ISS SOPs, processes, systems and regulations and participation in improvement initiatives, taskforces, and committees to improve ISS processes. Additional responsibilities may be assigned based on level of experience and expertise.
Ability to educate others on ISS SOPs and processes, identify compliance issues and escalate accordingly to senior management.
Liaise directly with sponsor-investigators and ISS Review Committee members, including Medical Directors, Regional Medical Liaisons, Pharmacovigilance, Biostatistics, Legal/Regulatory and Clinical Supplies.
Actively participate in the review and evaluation of investigator-sponsored trial submissions for compliance with company policy and alignment with corporate strategy.
Track the execution of the ISTs and budgets from approval decisions through execution of contract payments, and outcomes.
Critically evaluate budgets for proposed ISTs, including accountability of accurate forecasting of ISS milestone payments.
Maintain an accurate and current database on the status of all ISTs.
Partner with Clinical Trial Associates in study management and conduct of ISS studies, including mentoring as appropriate.
Forecasting study drug requirements to Clinical Supplies and arranging for shipping and monitoring of study drug supply
Accountable for ISS records and history to be audit ready
Identifies when issues should be escalated to ISS Operations management and seeks input from appropriate team members.
- Experience in managing budgets and forecasts, as relate to clinical trials
- Demonstrated superb organizational, time management and communication skills (verbal and written)
- Demonstrated experience working on multiple projects simultaneously
- Strong interpersonal skills with the ability to interact with all levels of the organization
- Strong problem-solving, follow-through and decision-making skills for assigned programs with minimal supervision
- Proven ability to work both independently and in a team setting, and to meet set goals by managing own timelines
Exceptional project management, including managing multiple complex projects from start to completion
Demonstrated involvement in cross-functional clinical trial teams and capabilities in managing trial planning, initiation, executing, and reporting activities.
Demonstrated functional knowledge of Good Clinical Practices, Corporate policies and standard operating procedures as well as knowledge of applicable external regulatory requirements and guidelines
Bachelor Degree in business or science area with 4+ years pharmaceutical/biotechnology industry experience in clinical research, clinical operations or medical affairs