What are the responsibilities and job description for the Director Clinical Data Management (Oncology) position at Pharmaceutical / Biotech Industry?
Director Clinical Data Management (Oncology)
Boston MA, onsite
Summary :
The Director of Clinical Data Management will oversee the Oncology therapeutic area . This role will contribute to the strategy for Oncology in collaboration with Clinical Data Strategy Operations head and will also support the growth and development of the group.
Daily activities include the following :
Provide leadership and direction to the Clinical Data Management Operations team, ensuring alignment with organizational goals and objectives.
Oversee the management of clinical data within the Oncology group, ensuring adherence to data management processes and regulatory requirements.
Collaborate with cross-functional teams, including Clinical Operations, Clinical Development, Biostatistics, Pharmacovigilance, and Regulatory Affairs, to ensure the integration and accurate clinical trial data.
Mentor and support data management professionals, providing guidance, training, and performance evaluations to ensure the highest level of productivity and quality.
Establish and maintain relationships with external vendors, ensuring effective communication and collaboration to meet project timelines and deliverables.
Understand and streamline processes for maximum efficiency, ensuring they meet the needs of the organization and comply with industry standards.
Monitor project budgets, resource allocation, and timelines to ensure successful execution of clinical data management activities.
Update industry trends, best practices, and regulatory requirements related to clinical data management, and implement necessary changes to maintain compliance and enhance operational efficiency.
Lead and manage both CRO fully outsourced trials as well inhouse functional service provider trials.
Required :
Bachelor's degree in a scientific or related field
Minimum of 10 years experience in clinical data management
Recent or current Oncology experience is a must.
Proven experience in a leadership role overseeing clinical data management operations.
Strong knowledge of industry standards, regulatory requirements, and best practices related to clinical data management.
Understanding of clinical trial methodologies, data collection processes, and data analysis techniques.
Demonstrated ability to lead and motivate a team, providing guidance and support.
Strong collaboration and interpersonal skills, with the ability to communicate effectively with cross-functional teams, external vendors, and senior management.
Problem-solving and decision-making abilities, with a track record of successfully resolving complex issues.
Proficiency in Data Management Review systems and tools (JReview, Spotfire etc.) to enable effective data review as well as operational metrics.
Proven track record in managing direct reports.
Experience with managing outsourced service providers and CROs