Description
Our Senior Clinical Team Lead is an expert in clinical project management with an extensive background in clinical research, project management, and expert knowledge of ICH-GCP, and applicable Federal and international research guidelines and regulatory requirements. The Sr CTL ensures all clinical tasks meet client and Sarah Cannon expectations and are completed in accordance with the contract, protocol, project plans, ICH-GCP guidelines, and applicable Standard Operating Procedures (SOPs). The SCTL provides leadership in the development and execution of clinical trials by overseeing the clinical project management and operational responsibilities essential to successful development and execution of multiple assigned complex clinical research trial projects.
Duties
- You will assist contribute to and present at project Kick-Off Meetings and Investigator Meetings as needed.
- You will proactive and continuous assessment of project needs for clinical resource forecasting to ensure timelines and deliverables are met while adhering to quality standards and supporting financial targets.
- You will plan and track clinical activities throughout the lifecycle of assigned study projects.
- You will proactively identify and present project-related risks and facilitate resolutions both in and across functions.
- You will create and maintain Clinical Project Documents, including but not limited to clinical study plans, trackers, and team training materials.
- You will develop and conduct study team training.
- You will review performance metrics for assigned CRA team, including but not limited to site visit reports and other clinical study deliverables.
- You will manage enrollment and, as applicable, slot allocation for sites assigned to designated trials.
Qualifications
- Bachelor’s Degree (4-year program).
- 7 years' demonstrated work experience within the clinical research industry, in a clinical management role, with prior experience as a Sr. CRA, Clinical Team Lead, or equivalent role.
- A minimum of 2 years direct Oncology experience in Phase I.
- Expert knowledge of scientific, medical, and regulatory terms.
- Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, Microsoft Office software including Excel, PowerPoint, Word.
- Excellent professional writing and communication skills including demonstrated ability to conduct effective training.
Qualifications preferred
- A Master's Degree (2-year program).
- ACRP, CCRA or CCRP, PMP or equivalent industry certification.
- 10’ years direct oncology experience in Phase l and Phase II.
