Manager, Global Data Standards

Job Description

Working closely with the Global Clinical Data Standards (GCDS) Director of Delivery Management within the Global Data Management & Standards (GDMS) organization, the Global Data Standards Manager is responsible for the development, implementation, and oversight of the standards delivery framework and associated processes that drive end-to-end planning, delivery, and governance of GDMS standards components. The Manager may also lead or serve as a member of various GCDS and cross-functional teams within GDMS.

The Global Data Standards Manager is responsible for the ongoing management and timely delivery of standards and governance related deliverables produced by GCDS, within his/her defined scope. The Manager proactively engages with stakeholders inside and outside of GCDS to ensure standards and governance delivery in adherence to applicable processes, procedures, standards, and clinical program requirements.

The Manager is also responsible for the management and supervision of GCDS personnel. This includes responsibility for career development, performance objectives, ongoing performance feedback and recognition as well as annual performance appraisals for staff under his/her assigned area(s). The Manager will also participate in recruiting, interviewing and selection of new hires.

Primary Activities

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

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

• In support of the Director, Delivery Management GCDS, ensures 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.

• Supports audits and inspections as required.

Minimum education required:

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

Required Experience and Skills:

• Minimum of 7 years’ experience in Clinical Data Management (or related discipline)

• Minimum of 2-3 years’ experience in direct-line people management

• Experience managing clinical data management processes including electronic Case Report Form (eCRF) design, clinical database development and validation, user acceptance testing, external data management, data extraction, and reporting

• Exceptional communication skills (oral and written), with the ability to communicate with both the technical and business functional areas

• Exceptional people and thought leadership skills, with the ability to think strategically and to influence others.

• Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in the management of multiple projects.

Preferred Experience and Skills:

• 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 applying formal project management tools and processes.

• Experience building and/or developing an organization.

#EligibleforERP

MRLGCTO

#ONEGDMS

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. 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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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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.

Employee Status:

Relocation:

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Flexible Work Arrangements:

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Requisition ID:R223474