Clinical Team Manager – HemOnc

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

📋 Description

• Oversee the clinical operational and quality components of assigned low- to moderate-complexity studies in alignment with ICH GCP standards.

• Create clinical tools, monitoring strategies, monitoring guidelines, data quality plans, and the clinical portions of the Master Action Plan.

• Ensure the prompt establishment, organization, content, and quality of local and central Trial Master File sections.

• Engage in the design of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents.

• Collaborate with project managers to prepare, organize, and deliver client meetings, including bid defense and hand-off discussions.

• Work alongside clinical and cross-functional teams to achieve project objectives.

• Lead team meetings and uphold timelines, resources, interactions, and quality standards.

• Implement and educate teams on standardized clinical monitoring procedures.

• Ensure the timely archiving of documents and study materials.

• Prepare and oversee clinical activity timelines and metrics, provide project status updates, review projects using tracking tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.

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

• Conduct Accompanied Field Visits and oversee project financials in smaller regions as necessary.

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

• Coordinate study start-up activities and ensure timely submissions to ethics committees and regulatory bodies.

• Guarantee that essential document quality meets Regulatory Compliance Review standards and follow up on any ethics committee inquiries.

• Provide insights into clinical activity forecasts.

• Manage clinical resources, delegate clinical tasks, and identify additional resource needs.

⛳️ Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.

• At least 5 years of pertinent experience in clinical research, encompassing clinical trial operations, study management, clinical monitoring, or similar clinical research activities.

• Transferable experience in healthcare, nursing, medicine, or related fields may be acceptable when combined with clinical trial experience, provided the candidate showcases significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities.

• Must possess FSO/CRO experience.

• Must have Global CTM experience managing international teams.

• Experience in one or more indications such as Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and/or CART-T.

• Familiarity with the practices, processes, and requirements of clinical monitoring.

• Solid comprehension of relevant regulations, including ICH/GCP and FDA guidelines.

• Proficient in computer skills, including Outlook, Excel, Word, and similar applications.

• Strong oral and written communication skills, with proficiency in the English language.

• Excellent leadership, planning, organizational, interpersonal, problem-solving, judgment, decision-making, financial, budgeting, forecasting, fiscal management, and attention-to-detail capabilities.

• Able to function effectively in a dynamic environment with complex or ambiguous situations.

• Capable of assessing workload against project budgets and adjusting resources as necessary.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Work within a global team environment.

• Frequent opportunities for domestic and international travel.