Clinical Team Manager

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

📋 Description

• Oversee the clinical operational and quality elements of assigned low- to moderate-complexity studies, ensuring compliance with ICH GCP standards.

• Take on Clinical Study Manager duties for small or less complex projects as necessary.

• Create clinical tools, monitoring plans, and guidelines, while contributing to data quality and master action plans.

• Establish, organize, maintain, and archive relevant sections of the Trial Master File and study materials.

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

• Work collaboratively with project managers to prepare and deliver presentations at client meetings, including bid defenses and hand-off meetings.

• Facilitate clinical team meetings and coordinate with clinical and cross-functional teams to uphold timelines, resources, quality, and effective interactions.

• Implement and provide training on standardized clinical monitoring processes.

• Track clinical activity timelines and metrics, offering status updates, reviewing projects and monitoring visit reports, executing recovery actions, and managing CRF collection and query resolution.

• Conduct or co-monitor clinical trials, evaluating performance against contractual obligations.

• Carry out Accompanied Field Visits and oversee project financials in smaller regions as needed.

• Communicate with study sites concerning protocols, patient participation, case report forms, and study-related issues.

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

• Review and address ethics committee inquiries, ensuring the quality of essential documents.

• Contribute to forecasts of clinical activities and manage clinical resources, responsibilities, delegation, and any additional resource needs.

⛳️ Requirements

• A Bachelor's degree or equivalent, along with a relevant formal academic or vocational qualification.

• Over 5 years of pertinent experience in clinical research, including clinical trial operations, study management, clinical monitoring, or similar activities.

• Transferable experience in healthcare, nursing, medicine, or related fields may be considered, provided the candidate demonstrates notable clinical expertise, therapeutic area knowledge, and direct patient care responsibilities.

• Experience with FSO/CRO.

• Global Clinical Trial Management experience leading international teams.

• Expertise in indications such as 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 CAR-T.

• Strong leadership, mentoring, and training capabilities.

• Excellent planning and organizational skills.

• Effective interpersonal and problem-solving abilities.

• Capacity to work within multicultural matrix organizations and adapt to changing environments with complex or ambiguous situations.

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

• Strong judgment and decision-making skills.

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

• Ability to assess workload against project budgets and adjust resources accordingly.

• Knowledge of financial management, including budgeting and forecasting.

• Keen attention to detail.

• Understanding of ICH/GCP and FDA guidelines.

• Proficient computer skills, including Outlook, Excel, and Word.

• Willingness to travel frequently both domestically and internationally, including driving to site locations.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• A workplace focused on scientific excellence.

• Opportunities for domestic and international travel.