What are the responsibilities and job description for the Executive Director of Data Management (Office OR Remote) position at Infinity Tech Group Inc?
Job Details
Description
The Executive Director of Data Management (DM) is the Head of DM with broad responsibilities for developing and implementing the strategic vision of the DM function and overseeing all DM activities from study start-up through close-out to ensure quality data delivery with aggressive timelines. The DM Head will build and lead a high-performance DM team and establish standards and capacities to ensure the highest standard in data integrity and quality of clinical data for global drug registrations. He or she is responsible for establishing a proper DM resource model and efficient infrastructures and process and maintaining an engaging and collaborative culture.
The position reports to the Head of Biometrics and interacts regularly with a diverse group of internal and external stakeholders. Demonstrated leadership for leading a high-performance DM team and leading cross-functional collaborations is a must.
Responsibilities:
- Develop and implement short-term and long-term strategic vision for DM in term of resource model, infrastructure, and capabilities.
- Responsible for DM resource planning, staff and vendor management, and DM budgets.
- Manage CRO and internal resources on all DM activities from database setup, data collection and cleaning, ongoing data quality monitoring, and database lock to meet aggressive timelines with highest standard of integrity and quality.
- Lead DM vendor and technology evaluation, qualification, and selection.
- Take leadership role in cross-functional efforts for establishing data standards and streamlining process to improve efficiency and quality.
- Provide leadership and direction for DM team and outsourced activities.
- Oversee DM operations to ensure high quality DM deliverables in time, such as database go-live, ongoing data quality monitoring, and database lock.
- Provide subject matter expertise and guidance to team members as needed.
- Ensure highest standard in data quality for smooth and timely database lock.
- Ensure compliance with SOPs, Google Cloud Platform, ICH, global drug registration standards.
- Ensure DM documentation in an audit-ready state.
- Lead development and implementation of DM SOPs, work instructions, and DM standards for both in-source and out-source models.
Qualifications:
- B.S. or equivalent degree
- At least 18 years of experience in clinical data management in a CRO, pharmaceutical, or biotech environment
- At least 5 years of experience in building and leading the DM function.
- Extensive leadership skills to manage a high performing DM team and cross-functional collaborations
- Subject matter expertise in data management
- Good interpersonal communication and presentation skills
- Oncology study experience preferred
- Experience in bringing DM function in house preferred
Physical Requirements Office Setting
Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
