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Senior Clinical Data Manager (Multiple Positions)

Company: Labcorp
Location: Princeton
Posted on: May 16, 2022

Job Description:

Lead studies including (but not limited to) a combination of healthy volunteer and patient populations, multi-site, complex protocol design, and strong client management required or reduced timelines. Ability to organize and effectively prioritize workload and deliverables. As the Study 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) or FSP Lead (or designee) 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 FSP Lead (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 (or designee), 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. Track scope changes and work with the Project Manager or 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. 100% telecommuting: Reports to company headquarters in Princeton, NJ. Can work remotely or telecommute. Qualifications: Master's degree in Engineering, Computer Science, Life Sciences, Health Science, Pharmaceutical Science, Information Technology, Regulatory Affairs, or related and four (4) years of experience in the job offered or closely related occupation. In lieu of a Master's degree in Engineering, Computer Science, Life Sciences, Health Science, Pharmaceutical Science, Information Technology, Regulatory Affairs, or related and four (4) years of experience in the job offered or closely related occupation, employer will also accept a Bachelor's degree in Engineering, Computer Science, Life Sciences, Health Science, Pharmaceutical Science, Information Technology, Regulatory Affairs, or related and six (6) years of experience in the job offered or closely related occupation. Position also requires demonstrated experience with the following: Electronic Data Capture; Combined early or late-stage Data Management; Direct sponsor management; Technical mentoring; Handling customer negotiations; Managing Scope of Work and budgets; Clinical trial process, clinical operations, biometrics, and system applications to support operations; Relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies; Providing SME guidance on Data Management practices; and Representing Data Management in bid defense meetings, providing innovative solutions to meet client needs. Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our - -

Keywords: Labcorp, Trenton , Senior Clinical Data Manager (Multiple Positions), Executive , Princeton, New Jersey

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