What are the responsibilities and job description for the Director/Senior Director, Clinical Operations (Boston, MA) position at Cedent Consulting Inc?
Director / Senior Director, Clinical Operations (Boston, MA)
Summary :
Find out if this opportunity is a good fit by reading all of the information that follows below.
As the Head of Clinical Operations, you will lead the clinical operations strategy and oversee clinical studies, driving industry-leading execution speed and quality. As a key functional leader and subject matter expert, you will collaborate with cross-functional program teams to achieve departmental and corporate goals.
Responsibilities :
- Lead strategic planning and daily study operations, focusing on site oversight from startup to closeout, patient enrollment, monitoring, compliance, and data flow with clinical sites, CROs, and vendors.
- Develop and implement global operations strategies with Clinical Development to optimize timelines while ensuring high quality and integrity.
- Collaborate with cross-functional teams to deliver clinical studies on time and within budget, ensuring quality in line with protocols, ICH GCP, regulatory guidelines, and patient safety.
- Manage clinical CROs, acting as the primary contact to identify and resolve issues, ensuring adherence to agreements, timelines, and quality standards.
- Build and maintain strong relationships with global investigators, clinical site staff, and vendors.
- Generate reports to communicate study progress and key metrics to Leadership and program teams.
- Partner with Finance and vendors to maintain accurate budgets and cost tracking for each clinical study.
- Contribute to preparation and review of key study documents, including protocols, informed consent forms, case report forms, and clinical study reports.
- Oversee the collection and analysis of clinical trial data, ensuring data accuracy and integrity.
- Participate in creating and updating clinical operations SOPs and coordinate with Quality Assurance for site and vendor audits.
- Hire, train, and develop the Clinical Operations team, fostering a culture of collaboration, accountability, and continuous improvement.
Requirements :
This is a full time position.
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