Job Description Under the direction of the applicable management, the Principal Clinical Data Manager (PCDM) is responsible and accountable for ensuring quality and consistent end-to-end data management deliverables which can include trial and standards level data collection specification authoring. He/she is also accountable for providing comprehensive technical guidance and design-specific recommendations to the Lead Clinical Data Managers (LCDMs) when appropriate. The PCDM is able to work independently or within a team or as a team leader with equal effectiveness. They will interact with staff across our Company's sites and serve in the role of mentoring, guiding, and providing project leadership for LCDMs as assigned. Primary Activities Include, But Are Not Limited To All required activities outlined in the Lead Clinical Data Manager (LCDM) job description at the discretion and direction of management. Helps ensure quality and consistency of data management requirements, specifications and/or deliverables across trials and across therapy areas. This may include, but is not limited to: Data Collection and/or data validation specification authoring and/or consultation. End-to-end review of design/data validation specifications consistent with Protocol requirements, Therapeutic Area (TA) needs, and data requirements. Subject Matter Expert (SME) level peer review/quality checks of specification documents and other deliverables. Provides process and technical related recommendations and guidance to LCDMs. Supports LCDMs via consultancy and teaching by example and review as well as mentoring as needed. May be expected to partner with functional area representatives to ensure: Appropriate use of database standards. TA/program-level consistency related to database development specifications, data collection guidance and needs, and data validation requirements and tools, including external data in support of the GDO TA lead. Keeps abreast of end-to-end clinical data management processes, procedures, trends and regulations through interaction with stakeholders and experts both within and outside of our Company across the industry. Identifies and develops areas for improvement data management processes, standards and tools. May lead continuous improvement special projects, or any other data management tasks deemed appropriate by management. Primary leadership and oversight of all GDO Standards related roles, responsibilities and activities including but not limited to: GDMS Standards Review Committee representation and full engagement with GCDS. GDO Standards Committee & GDO TAST Governance & Leadership, including quality, efficiency, effectiveness, and resourcing. GDO Standards Training Program development, implementation and continuous maintenance. Primary Standards SME for all GDO processes involving standards activities. May serve as line manager for up to 4 direct reports. Education B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline. Experience Requires at least 3 years' experience in Clinical Trial Data Management field. OR At least 5 years' experience in Pharmaceutical and/or medical or research related field. Knowledge And Skills Thorough knowledge of end-to-end clinical data management and clinical development process. Process oriented with QC/QA profile, technical expertise, standards, preferably with CDISC/SDTM knowledge. Demonstrated strong leadership and project management skills. Ability to be flexible, to multi-task and work independently. Strong organizational, communication, and problem-solving skills. Ability to establish and maintain good working relationships with the different functional areas and work cross-functionally as part of a team. Who We Are … For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What We Look For … In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit, and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth . 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. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully 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. Employee Status Regular Relocation No relocation VISA Sponsorship No Travel Requirements 10% Flexible Work Arrangements Hybrid Job Posting End Date 11/4/2024 A job posting is effective until 11:59:59 PM 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 R316427
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