- Lead and supervise the trial team to ensure the successful execution of the clinical trial according to the development plan, budget, and timeline.
- Author and approve clinical trial documents and related plans.
- Review and approve CRFs, CRF completion guidelines, and data review plans.
- Oversee the identification and selection of investigator sites.
- Plan, conduct, and participate in Investigator's Meetings.
- Collaborate with the team to ensure timely delivery of clinical trial supplies and address any issues proactively.
- Coordinate with cross-functional team for the selection and management of clinical trial vendors.
- Monitor and manage the budget for clinical trial(s) and oversee contracts with CROs and vendors.
- Attend site visits to assess trial progress and compliance.
- Ensure compliance with monitoring plans and identify data quality issues.
- Provide status reports on trial progress to management.
- Mentor other team members and manage multiple clinical trials.
- Support departmental initiatives and improvements.
- Serve as a subject matter expert during regulatory inspections.
- Perform other duties as necessary.
- Required: B.S/B.A. degree. Preferred field in Science/Healthcare.
- 6+ years in a pharmaceutical/biotech company or similar organization.
- 3+ years managing clinical trials.
- Ability to prioritize and manage multiple tasks efficiently.
- Excellent written and verbal communication skills.
- Strong knowledge of project management software and regulatory requirements.
- Proven ability to collaborate effectively with vendors.
- Lead cross-functional teams and external vendors successfully.
- Largely sedentary role with occasional filing tasks.
- Operates in a professional office environment.
- Up to 25% domestic and/or international travel.
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Senior Clinical Trial Manager - Waltham, United States - Apellis
Description
Senior Clinical Trial Manager Position at Apellis Pharmaceuticals, Inc.
Position Summary:
The Senior Clinical Trial Manager is accountable for overseeing and managing clinical trial(s) in a fast-paced setting with limited supervision. They play a crucial role in contributing to an environment of learning and process enhancement.
Key Responsibilities:
Requirements:
Experience:
Skills & Abilities:
Work Environment:
Travel:
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company dedicated to developing transformative therapies for challenging diseases. With cutting-edge science, they aim to address critical medical needs.
EEO Statement:
Apellis is committed to equal employment opportunities, promoting diversity and inclusion in the workplace.
Please note this description does not encompass all job duties; responsibilities may evolve over time.
