Manager, Data Management

Company Name:
Clinical Blend, LLC
Overview/Summary of
Oversee the staffing and resource needs based on project load and internal capacity. Provide input to both proposals and budgets. Track milestones in projects, ensuring accurate and timely completion of data management activities. Provide leadership to staff including training, delegating tasks to, supervising the work of, and conducting career development for direct reports. Conduct hands-on data management activities as needed.

A. Essential Functions:

Project Management Activities
Participate in determining and establishing project timelines based on individual projects.
Plan the client deliverables and manage project budgets; create Data Management Plans.
Function as liaison to the client firms to discuss project issues, updates, and concerns.
Identify critical project tasks/issues and recommend courses of action to expedite the project objectives.
Prepare and distribute periodic project progress reports and oversee preparation of client correspondence.
Conduct data coordination staff training as necessary, plus contribute to individual career development and goal setting.
Delegate and supervise tasks given to subordinates
Develop and maintain guidelines for data management plans
Critically review business proposals for pharmaceutical clinical trial opportunities, when necessary.
Coordinate the receipt and processing of information for projects (coding dictionaries, format libraries, and transfer of database specs) as well as electronic data received
Direct and oversee project-specific initiation and orientation, as necessary, particularly through facilitation of effective kick-off meeting and participation in
Conduct regular Project Team meetings and prepare and distribute minutes in the form of Action Items with assignments and due dates. Oversee and coordinate activities of Team members.
Coordinate, based on project progress, recommendations to appropriate line managers in all other disciplines.
Maintain knowledge of FDA guidelines, procedures, SOPs; assist by upgrading existing SOPs
Coordinate with IT to ensure appropriate hardware and software are in place
Upgrade the existing systems to ensure data entry, data cleaning, and query processing systems are timely and efficient
Define edit checks to be programmed for the study/project.
Ensure the completion of all quality-control measures necessary for the finalization and transfer of data and related materials to the client
Identify the achievement of milestones to the project team

Technical and Hands-on Responsibilities
Maintain a system /process to manage CRF standards and construction
Conduct data review and query generation
Update database to correct data errors
Create coding and review guidelines; code CRF verbatim
Execute standard programs.
Create data edits and data queries.
Code medical terms with WhoArt and MedDRA.
Ensure project consistency.
Evaluate progress of study by generating status reports.

B. Non-Essential Functions:
Participate in the building, testing, and validating of databases; ensure databases are validated and ready for transfer and/or analyses
Assist in Business Development activities such as identifying potential projects with current clients plus identifying possible new clients, whenever appropriate and possible.
Participate in proposal generation and final review process.
Participate in capability presentations, as needed.

C. Skills Required:
Keeps current with information on Pharmaceutical R&D and therapeutic area
Ability to be both a Leader and a Mentor to data staff.
Possess strong analytical skills.
Possess strong written and verbal communication skills.
Ability to work in a fast-paced environment with changing priorities.
Function effectively and efficiently as a "Team-Player".
literacy in MS Excel and Access; any SAS knowledge is a strong plus

D. Education and Work Experience:
Degree in life science, or equivalent, from an accredited college or university.
Minimum of 4 years related experience in a clinical setting along with management experience.
Prior experience supervising direct reports is a plus (preferably from a pharmaceutical or clinical study setting).
Thorough knowledge of the pharmaceutical clinical drug development process and team-based matrix management.

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