Global Clinical Data Standards Therapeutic Area Lead

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Job Title: Global Clinical Data Standards Therapeutic Area Lead
Location: New York, NY, Mid-Atlantic United States,

Company: Merck
Industry Sector: Agribusiness

Job Description: Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

The Associate Director, Global Clinical Data Standards Therapeutic Area Lead is a subject matter expert in the area of data standards as it relates to developing clinical data collection tools and mapping. The individual may be responsible for coordinating data processes related to new therapeutic areas, which may require them to create standards from scratch rather than work to update or change existing standards. Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple company sites. Mentors, guides, and provides project leadership for junior staff as assigned. May participate in process design and/or implementation initiatives.

The GCDS TA Lead is responsible for:

Defining standard collection and mapping data definitions, ensuring alignment with industry (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
Leads standards data governance reviews
Contribute to the definition and maintenance of business processes related to the definition, use, maintenance and sharing of clinical data standards
Led or participate in department initiatives, cross-functional working groups and process improvement activities
Participate in cross-functional project teams; established 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 Merck guidelines and SOPs.
Able to work independently or as a team member with equal effectiveness. Interacts with staff across multiple Merck sites

#ONEGDMS

Education:

B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline; or 8 years of relevant experience.

Experience:

8+ years' work experience which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years' work experience of which 2 years need to be in clinical data standards development.

Knowledge and Skills:

Advanced knowledge and leading-edge skills in clinical data standards.
Study Data Tabulation Model (SDTM) knowledge
InForm expertise
Analysis & Reporting experience
Program-level clinical and business requirements knowledge
Communication/presentation skills
Education/training/facilitation skills
Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects. Knowledge of clinical data management.

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#EligibleforERP
MRLGCTO

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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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.

Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:
$117,600.00 - $200,100.00

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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:
Remote Work

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):

Number of Openings:
2

To apply please click on APPLY TO THIS POSITION

Job Post Date: 12/21/22