Lead Data Manager
Job Overview :
Data Management leadership on studies and take responsibility for the development of the project
documentation, system set-up, data entry and data validation procedures and processes assigned to
more junior staff. Assume responsibility for all DM activities (from study start-up to database
lock) according to client quality expectations, within project timelines and budgets.
Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors.
Work directly with Sponsors to understand their direct requirements and lead implementation of
those requirements. Regularly review client specific process to ensure they remain optimal for
Sponsor and Covance.
The Principal Clinical Data Manager will work with the leadership team to provide guidance,
mentoring and training to DM in order to ensure best working practices are maintained.
Participate in bid defenses, capabilities presentations, and other client engagements regarding
budget, scope of service, or DM processes.
Support the budget development process for Data Management opportunities.
C. Essential Job Duties :
Lead studies including (but not limited to) a combination of healthy volunteer and patient
populations, multi-site, complex protocol design, strong client management required or
reduced timelines.
As the lead data manager, be accountable for all DM deliverables as assigned per the
established timeline; providing instruction to their DM study team(s) and review of their study
team’s output to ensure the highest quality, while adjusting resource allocations accordingly.
Ensure that all allocated projects are carried out in strict accordance with the relevant
protocols, global harmonized SOPs, and the specified standards of GCPs.
Work with the Project Manager(s) to build timelines to meet contracted milestones by
communicating with leads in different disciplines and the full project team as necessary,
including at study initiation meetings.
Provide DM project team leadership and accountability; leads data focused internal project
team meetings; meets frequently with the study leads of EDC Design, SAS Programming,
Statistics, and PK to ensure that all deliverables are planned and coordinated
intradepartmental; proactively identifies potential risks / mitigations, effectively communicates
data-driven discussions in order to achieve database lock dates; keeps the Project Manager or
designee apprised of project progress.
Maintain awareness of other Biometrics functional group deliverables to be able to support
risk and mitigation strategies, including impact on DM resources or deliverables and consult
with Project Manager or designee and / or functional group management as necessary.
Keep Project Manager, Biometrics management team and / or sponsor services informed of
pertinent project or sponsor related information (i.e., budget status, work scope changes,
timeline impacts).
Coordinates the receipt and inventory of all data related information, from clinical sites and
vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate
documentation and procedures are performed upon project completion.
Develop and maintain client relationships and review client satisfaction surveys. Implement
appropriate action plans including driving process improvements and team training.
Applies corrective interventions where necessary to maintain project budget compliance and
profit expectations. Track scope changes and work with the Project Manager or Functional
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Service Provider (FSP) Lead / or desegnee ensure that Sponsor approval is received, and the
scope change processed.
Provides leadership, mentorship, and coaching in DM related clinical trial processes,
department technical capabilities, and associated turnaround durations to the internal study
team.
Provide support to DM supervisors and managers on the performance evaluation of other team
members; provide constructive feedback to aid in career development, interpersonal skills, and
achievement of competency standards.
Accountable for learning new DM technologies and applied processes, keeping up to date with
industry wide technology and feasibility for process improvement at Covance.
- Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
- Have input in writing, reviewing, and updating SOPs and associated documents as required.
- Maintain accurate records of all work undertaken.
- Perform reconciliation of the clinical database against safety data, laboratory data or any other
third-party data as appropriate. Utilize local laboratory systems and batch data load facilities
where appropriate. (Operations Task can say Supervise or Guide this task).
Represent Data Management and where necessary overall Clinical Data Solutions in new
business opportunities.
Attend and action client or internal audits as appropriate and resolve all issues within an
appropriate timeframe. Address client comments with the study team.
Works with management team to develop and implement directional strategy by providing
technical input into discussions and rolling out training / mentorship to DM staff as required.
- Actively promote Clinical Data Solutions services to sponsors whenever possible.
- Collaborate with applicable functional teams during study budget creation process.
- Participate in bid defenses, capabilities presentations, and other client engagements regarding
budget, scope of services, or processes.
Actively represent Data Management at internal strategy calls, pricing review calls, and other
meetings as required for scope / pricing decisions.
- Support the budget development processes for Data Management.
- Performs other related duties as assigned by management.
Education / Qualifications :
University / college degree (life sciences, health sciences, information technology or
related subjects preferred).
Experience and / or education plus relevant work experience, equating to a bachelor's
degree will be accepted in lieu of a bachelor’s degree.
Experience : Minimum Required :
Minimum Required :
10 years of combined early or late-stage DM experience with four years of direct sponsor
management and 3+ years technical mentoring experience. Proven experience in handling
customer negotiations and experience with managing Scope of Work and budgets.
Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and
system applications to support operations.
Proven ability to lead by example on project strategies and achievement of department
goals, objectives and initiatives and to encourage team members to seek solutions.
Working knowledge of the relationship and regulatory obligation of the CRO industry
with pharmaceutical / biotechnological companies.
- Time management skill and ability to adhere to project productivity metrics and timelines.
- Ability to work in a team environment and collaborate with peers.
- Ability to mentor junior members of the department, providing SME guidance on DM
practices.
Experience of representing DM in bid defense meetings, providing innovative solutions to
meet client needs.
- Good organizational ability, communication, and interpersonal skills.
- Team working skills and good collaborator skills.
- Constructive problem-solving attitude while deadline focused with time demands,
incomplete information or unexpected events.
Preferred :
Through knowledge of Covance, the overall structure of the organization and Standard
Operating Procedures (SOPs).
- Four or more years of Electronic Data Capture experience.