Job Description:

Director, Clinical Affairs

Job Locations

US-MD-Baltimore | US-MA-Cambridge

Summary of Major Responsibilities

The Director, Clinical Affairs will be responsible for large-scale Clinical Trials Management in a cancer screening company. They will coordinate and supervise functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Head of Clinical Development. Additionally, they will be responsible for performance metrics and quality of deliverables in the clinical trial in a matrixed environment.

Essential Duties and Responsibilities

Manages study enrollment, quality, timelines and budget with the cross-functional leads, CROs, and vendors to ensure that overall project objectives are met
• Builds and maintains solid professional relationships with clinical site staff and CRO partners


• Works closely with the CRO to ensure robust performance metrics are developed and carried out effectively to ensure study enrollment is successful and completed on time


• Tracks and analyzes data from the CRO and Thrive Data Management to ensure that robust ongoing data monitoring strategies are carried out effectively, ensuring delivery of high-quality data


• Proactively identifies and proposes mitigation strategies for study-related risks


• Coordinates and has input on the development of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements, IRB/EC submissions


• Responsible for reviewing and managing (if applicable) study related plans and processes, including Investigator agreements (CTA), monitoring plan, safety monitoring plan, lab manuals


• Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met


• Reviews essential document packages to enable timely site activations


• Reviews pre-study, study initiation, interim monitoring visit and study closeout visit reports. Assesses monitoring reports and loops back with broader team to provide updates. Directs investigator performance and adherence to protocol, and proactively escalates conduct issues and enrollment problems, as necessary


• Responsible for oversight on the maintenance of the eTMF and completeness at the end of the study; performs periodic QC of the eTMF


• Oversees the planning and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements


• Helps ensure that studies are "inspection ready" always

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Qualifications

• Bachelor's degree or equivalent in health/medical related area preferred


• 5+ years of experience in clinical project management conducting large-scale Ph 1-3 clinical trials in the pharmaceutical, biotechnology, and/or diagnostics industry


• A solid understanding of ICH guidelines, GCP, and specifically, each step within the clinical trial process


• Proficient in reviewing and assessing clinical data


• Budget forecasting and management experience


• Demonstrated ability to project manage teams and work in a fast-paced cross-functional team environment


• Proven proficiency in overseeing logistically complex studies being managed by a CRO


• Excellent interpersonal and decision-making skills.


• Demonstrates innovation; possesses drive, energy and enthusiasm to deliver the program objectives


• Possesses excellent planning, time management & coordination skills


• Excellent written and verbal communication skills

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.