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Clinical Affairs Program Manager
hace 2 meses
At Chronos Consulting, we are seeking a highly skilled Clinical Affairs Program Manager to join our team. As a key member of our global clinical affairs team, you will be responsible for developing strategies for the successful execution of clinical trials that demonstrate medical product safety and efficacy.
Key Responsibilities:
- Collaborate with company stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, and other research initiatives.
- Oversee the design of clinical trials, including protocol development, clinical trial discussions with regulatory authorities, and development of timelines and budgets.
- Manage the process of screening, qualifying, selecting, and contracting with investigators, sites, and vendors required for the conduct of clinical trials.
- Direct and manage necessary clinical trial approvals from Institutional Review Boards (IRBs) and Ethics Committees (ECs), and ensure studies are on track for site initiation, patient recruitment, and enrollment.
- Develop budgets for all clinical projects and adhere to company financial goals.
- Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.
- Develop, maintain, and expand collaborations with company stakeholders, clinical investigators, and researchers to optimize clinical development programs.
- Participate in the development of Standard Operating Procedures (SOPs) and work instructions to ensure internal files and clinical study files conform to Good Clinical Practice regulations and standards.
- Ensure adherence to protocols and compliance with regulatory guidelines, including FDA, ICH, ISO, and GCP.
- Identify clinical training needs and develop training materials for in-house and clinical site use.
Requirements:
- BS, BA, BSN, or RN or higher degree in the Life Sciences or related disciplines.
- Minimum 3+ years in clinical management position in the biopharmaceutical or device industry, Clinical Research Organization, or related field.
- Additional 4+ years direct experience in clinical trial management.
- Solid track record in successfully executing Phase I-III clinical trials.
- Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines.
- Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting.
- Knowledge of electronic data capture systems and web-based clinical trial management tools.
- Excellent interpersonal, written/verbal communication, computer, and organizational skills, strong program management and financial skills.
- Excellent command of the English language; both written and verbal.
- Collaborative team player with strong abilities to operate independently.
- Willing and able to travel domestically and internationally, as required (up to 40%).
