Data Standards Specialist, Global Clinical Data Standards

Job Description

Job Description

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines, and new indications for existing products. We ensure we conduct high-quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

The Data Standards Specialists is responsible for:

• Defining standard collection and mapping data definitions aligned with industry Clinical Data Interchange Standards Consortium (CDISC) standards and Health Authority regulations
• Ensuring the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables
• Supporting the definition of maintenance of additional standards library components
• Participate in standards data governance reviews
• The Global Clinical Data Standards (GCDS) Data Standards Specialist may contribute to the definition and maintenance of business processes related to the definition, use, maintenance, and sharing of clinical data standards
• Support department initiatives and participate in cross-functional working groups and process improvement activities
• Participate in cross-functional project teams; establish collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company
• Maintain knowledge of new technologies, industry standards, regulatory requirements, and company guidelines and Standard Operating Procedures (SOPs).
• Able to work independently or as a team member with equal effectiveness. Interacts with staff across multiple company sites
• May support any other project or perform any other data management task deemed appropriate by management

Education Minimum Requirement:

• Bachelors, or Associates Degree + 3 years clinical data standards implementation experience or High School/GED degree with 7+ years work years of clinical data standards implementation experience

Required Experience and Skills:

• Advanced knowledge of clinical data standards development and implementation CDISC SDTM expertise: In-depth knowledge of and experience with applying the CDISC Study Data Tabulation Model (SDTM)
• Broad comprehensive knowledge of the clinical trial process including data management (data collection, processing, storage, and retrieval) and worldwide regulatory data management and reporting requirements.
• Strong knowledge of the Drug Discovery Process, ICH, and GCP guidelines
• Knowledge of Analysis & Reporting
• Exceptional communication (oral and written) skills
• Must have an innovative spirit, outstanding interpersonal skills, and demonstrated proficiency in time management (ability to prioritize & manage multiple projects)

Preferred Experience and Skills:

• Electronic Data Capture expertise (e.g., InForm)

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., Kenilworth, 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.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R130854