Associate Director Clinical Operations
3 weeks ago
Title: Associate Director, Clinical Operations - Rare Disease/Oncology Background Needed
Location: Waltham, MA (Onsite 2 Days Weekly)
Key Responsibilities:
- Lead and oversee the execution of clinical trials within the rare disease and oncology therapeutic areas.
- Develop and implement strategic plans for clinical trial operations to ensure timely and successful completion of studies.
- Provide guidance and mentorship to clinical operations team members, fostering their professional growth and development.
- Collaborate cross-functionally with internal teams, including clinical development, regulatory affairs, medical affairs, and project management.
- Manage relationships with external vendors and clinical research organizations (CROs) to ensure quality and compliance throughout the trial process.
- Contribute to the development and implementation of standard operating procedures (SOPs) and best practices in clinical operations.
Requirements:
- Bachelor's degree in a scientific or healthcare-related field; advanced degree (e.g., Master's, PhD) preferred.
- Minimum of 5 years of trial management experience in clinical operations within the pharmaceutical or biotechnology industry, with a focus on rare diseases and/or oncology.
- Strong understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements governing clinical trials.
- Proven track record of successfully managing multiple clinical trials simultaneously, from initiation through closeout.
- Excellent leadership and communication skills, with the ability to effectively collaborate with cross-functional teams and external partners.
- Experience managing onsite/offsite clinical operations teams is preferred.
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