Clinical Data Manager jobs in Edison, NJ

Job Description

Position Description:

Manager, Operations and Reference Data Management, Global Clinical Data Standards

Working closely with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference Data Management within the Global Data Management & Standards (GDMS) organization, the Manager Global Data Standards – Ops and Reference Data Management is responsible for the day-to-day oversight of the Program Managers and their deliverables. This includes responsibility for career development, performance objectives, ongoing performance feedback and recognition, as well as annual performance appraisals for staff under their assigned area(s). The Manager will also participate in recruiting, interviewing and selection of new hires.

The Manager will mentor and guide Program Managers and ensure they work in a consistent manner, utilizing various project management methodologies/tools and integrating operational excellence best practices and communications to successfully execute on projects and enhance the overall capabilities of the Team.

Primary Activities

• Develops functional capabilities and ensures achievement of performance targets aligned with organizational goals and objectives.

• Collects and maintains data-driven delivery and operational metrics.

• Contributes to and provide insights into implementation of strategic direction.

In support of the Senior Director, Operations and Reference Data Management, ensures project delivery alignment with established guidelines and targets. Drives timely, aligned delivery of quality standards and governance data management deliverables and services in support of our company's research pipeline. Manages employee performance, career development, and organizational talent and succession planning. Proactively engages with key customers and stakeholders on behalf of GCDS to recognize potential value-creating opportunities and to drive improvements in quality, efficiency, and productivity across the organization. Keeps abreast of project management, clinical data standards, and regulatory requirements for clinical data standards, technology, and clinical data management disciplines; actively engages in industry forums. Leads and participates in organizational initiatives as assigned.

Position Qualifications:

Education Minimum Requirement:

• B.A. or B.S. degree, preferably in life sciences, information technology, or related discipline.

Required Experience and Skills.

• PMP certified with 2 years’ experience in project management or 5 years’ experience in project management.

• 2 years’ experience working in clinical development or clinical data management.

• Strong knowledge of the Drug Discovery Process, ICH, and GCP guidelines.

• Strong skills in project management methodologies.

• Must excel at interdisciplinary problem solving, have an innovative spirit, and demonstrated proficiency in the management of multiple projects.

• Ability to set priorities and mentor colleagues in project management, data standards and metadata management practices.

Preferred Experience and Skills:

• Experience in direct line people management.

• Knowledge of and direct experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, & HL7) and requirements for submission deliverables (e.g., SDRG, ADRG, Define.xml).

• Strong leadership and proven ability to drive results in a global, matrix environment.

• Ability to effectively collaborate and problem solve across both business and technical functions.

• Experience building and/or developing an organization.

#EligibleforERP

MRLGCTO

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NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Expected salary range:

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Job Posting End Date:05/22/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R292251