**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 Service Provider (FSP) Lead /or designee to 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. **Experience**: **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. - Pr