Senior/Principal Clinical Team Manager, Hematology/Oncology

📋 Description

• Oversee all clinical operational and quality elements of assigned studies, which are of low to moderate complexity, ensuring adherence to ICH GCP standards.

• Create clinical tools, including Monitoring Plans and Monitoring Guidelines, alongside the Data Quality Plan.

• Assist in formulating the Master Action Plan (MAP) for the provision of clinical-related documentation.

• Guarantee the timely setup, organization, content accuracy, and quality of relevant sections within the Trial Master File (both local and central).

• Work closely with the project manager to prepare, organize, and present during client meetings, which include bid defense and hand-off sessions.

• Maintain regular communication with the team and lead meetings to ensure timelines, resources, interactions, and quality standards are upheld.

• Accountable for implementing and training standardized clinical monitoring processes in accordance with the study and corporate standard policies.

• Ensure the completion of the final clinical deliverable within the specified contractual timeline by preparing and monitoring clinical activity timelines and metrics.

• Continuously monitor or co-monitor clinical trials to evaluate performance and ensure that contractual obligations are fulfilled.

• May engage with study sites regarding issues such as protocol adherence, patient participation, case report form completion, and other study-related matters.

• May oversee all start-up activities and ensure timely submissions to ethics committees and regulatory bodies (if applicable).

• Ensure that the quality of essential documents meets the expectations of Regulatory Compliance Review.

• May contribute to the preparation of forecast estimates for clinical activities.

• Responsible for managing clinical resources, including assignment, delegation of clinical duties, and identifying additional resource needs.

⛳️ Requirements

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

• Previous experience that provides the knowledge, skills, and abilities necessary for the role (approximately 5+ years).

• Strong leadership capabilities, effective in mentoring and training, and able to motivate and integrate teams.

• Excellent planning and organizational skills to facilitate effective workload prioritization.

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

• Ability to work effectively in a dynamic environment with complex or ambiguous situations.

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

• Good judgment and decision-making abilities.

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

• Ability to evaluate workload against project budgets and adjust resources as necessary.

• Strong financial understanding and knowledge of budgeting, forecasting, and fiscal management.

• High attention to detail.

• Solid comprehension of relevant regulations such as ICH/GCP and FDA guidelines.

• Proficient computer skills for effectively utilizing automated systems and applications such as Outlook, Excel, Word, etc.

🏝️ Benefits

• Flexible working arrangements.

• Professional development opportunities.