Clinical Team Manager – HemOnc

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee all clinical operational and quality elements of assigned low- to moderate-complexity studies while adhering to ICH GCP standards.

• Create clinical tools and assist in the development of Data Quality Plans, Master Action Plans, organization of the Trial Master File, CRFs, informed consent templates, and protocol-specific documentation.

• Work collaboratively with project managers to plan, organize, and deliver client meetings, including bid defense and hand-off sessions.

• Partner with clinical and other departments, lead team meetings, and ensure project timelines, resources, interactions, and quality are maintained.

• Implement and provide training on standardized clinical monitoring processes.

• Guarantee the timely archiving of study documents and related materials.

• Deliver final clinical outputs within contractual deadlines by tracking clinical activity timelines and metrics, providing status updates, executing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.

• Continuously monitor or co-monitor clinical trials to evaluate performance and fulfill contractual obligations.

• Conduct Accompanied Field Visits in smaller regions when appropriate and oversee project finances.

• Communicate with study sites regarding protocols, patient participation, case report forms, and other study-related matters.

• Coordinate study start-up activities and manage ethics committee and regulatory submissions as necessary.

• Ensure the quality of essential documents meets Regulatory Compliance Review standards and address any ethics committee inquiries.

• Contribute to forecasts related to clinical activities.

• Manage clinical resources, assign clinical responsibilities, and identify additional resource needs.

⛳️ Requirements

• Bachelor's degree or equivalent with relevant formal academic/vocational qualifications.

• 5+ years of pertinent experience in clinical research, encompassing clinical trial operations, study management, clinical monitoring, or related activities.

• Transferable experience in healthcare, nursing, medicine, or relevant disciplines may be considered alongside clinical trial experience if substantial clinical expertise, therapeutic-area knowledge, and direct patient-care responsibilities are demonstrated.

• Experience in FSO/CRO settings is required.

• Proven global CTM experience managing international teams is essential.

• Familiarity with one or more of the following indications: Ovarian, Sickle Cell, Non-Hodgkin's Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and/or CART-T.

• Strong leadership, mentoring, training, team motivation, and integration abilities.

• Excellent planning and organizational skills to prioritize workload effectively.

• Strong interpersonal and problem-solving skills within a multicultural matrix organization.

• Capacity to work efficiently in dynamic environments with complex or ambiguous scenarios.

• Knowledge of clinical monitoring practices, processes, and requirements.

• Strong judgment and decision-making abilities.

• Proficient verbal and written communication skills, including fluency in English.

• Ability to assess workload against project budgets and make necessary resource adjustments.

• Financial acumen with understanding of budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

• Comprehensive understanding of relevant regulations, including ICH/GCP and FDA guidelines.

• Proficiency in computer applications including Outlook, Excel, Word, and other automated/computerized systems.

• Willingness to travel domestically and internationally and drive to site locations as needed.

🏝️ Benefits

• Engage in collaboration and development as part of the daily experience.

• Receive reasonable accommodation for individuals with disabilities during the application/interview process and throughout employment.

• Enjoy equal opportunity employment.