Director Clinical Operations
Boston, MA (Hybrid)
$210,000 - $230,000
Job Description
An enticing opportunity awaits to become part of a dynamic environment alongside a dedicated, enthusiastic, and exceptionally skilled team. Embracing the position of Senior Director of Clinical Operations, you'll supervise operational responsibilities for designated studies and potentially embrace additional duties as they unfold. This role involves providing strategic and operational leadership to ensure the punctual, cost-effective, and high-caliber achievement of study milestones, while adhering to ICH/GCP, regulatory protocols, and SOPs. You'll contribute to the implementation of novel procedures, engage with stakeholders, and ensure seamless operations. Simultaneously, you'll manage junior staff, participate in training, and partake in annual reviews
Key Qualifications
- Possess over 15 years of experience in Clinical Operations or a related role, engaging with CROs and other vendors, and progressively assuming more significant roles.
- Familiarity with FDA/EMA regulations and ICH/GCP guidelines is essential, accompanied by prior involvement in collaborative, cross-functional settings.
- Proven track record in the selection, management, supervision, and fruitful cultivation of productive partnerships with multiple vendors and CROs.
- Highly motivated and enjoys working in a fast-paced, dynamic environment
- Strong organizational skills and ability to prioritize and multi-task
Roles & Responsibilities
- Supervise and direct clinical trials, ensuring their timely completion within budget, and adherence to SOPs, FDA/EMA regulations, and ICH/GCP guidelines.
- Act as the face of Clinical Operations ("ClinOps") in cross-functional study teams, Vendor, and CRO operational meetings, ensuring alignment with worldwide operational protocols.
- Handle the selection, initiation, management, and supervision of various vendors, including CROs, imaging services, central and specialized labs, eCOA providers, and compliance partners.
- Responsible for the review and oversight of tasks in study management plans for operations and all operational activities associated with clinical trials.
- Review/approve invoices, manage monthly accruals, and ensure timely payment processing for vendors, including investigative sites (as applicable).
Benefits
- Competitive compensation
- 401(k), Medical, Dental, Vision
- Performance based bonuses and incentives
