GDO Study Designer

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.

Position Description:

In connection with other General Data Management Service (GDMS) roles, the Study Designer (SD) role is accountable for:

• Ensuring quality and consistent E2E data management deliverables within a trial and across trials within their assigned TA.

• Ensuring the appropriate cross-functional perspectives are incorporated into the trial design and change control processes.

The role is responsible to support Trial design, including new components and updates to existing Library components as per Protocol/Program design requirements and Industry Standards, as well as monitoring and supporting the ongoing change control of data management deliverables for the life of the trial as needed.

The SD will interact with staff across multiple Functional areas and serve in the role of guiding Study Teams in applying global standards and industry best practices into E2E study design.

Primary activities include, but are not limited to:

• Support Study Design activities to ensure complete, comprehensive and high quality E2E design.

• Interact with study level resources (e.g. BARDS, Clinical, GDMS, External Vendors) to gather trial requirements (including new/updated components) and assure appropriate integration of all data sources.

• Ensures quality and consistency of the E2E data management specifications within and across trials in a Program and/or Therapeutic Area (TA). This may include, but is not limited to:

• Authoring data collection specifications for new and updated components.

• Including creation, submission and management of the Standards Request Package.

• Excluding COA & IRT Vendor Specs.

• Review and approval of Trial data collection specifications, including data Integration and data validation specifications.

• Support change management, as applicable.

• Author new data collection components or significant changes to data collection components.

• Review/approve adding additional existing data collection components.

• Ensures appropriate use of Global, TA and Industry Standards at the Trial level.

• Apply critical assessment, industry knowledge and expertise to make recommendations for efficient and effective data collection/design at Trial level, to optimize collection, review and system setup while delivering the requirements to stakeholders and customers.

• Identifies and develops areas for improvement in data management processes, standards and tools.

• May lead continuous improvement special projects, or any other data management tasks deemed appropriate by management.

• Mentor and train staff as needed.

Position Qualifications:

Education Minimum Requirement:(ex-Us, subject to local requirements):

• B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline AND 5 years' experience in Clinical Data Management in the Pharmaceutical industry.

OR

• 10 Years' experience in End to End Clinical Data Management Trial Design, Build and Execution AND HS Diploma.

Required Experience and Skills:

• Knowledge of the clinical development process, on the therapy area of interest and on how to translate Protocol requirements into data management specifications

• Expert knowledge of end to end clinical data management and the impact to downstream consumers

• Excellent analytical and creative problem solving, critical thinking, conflict resolution, communication, organizational, and multi-tasking skills

• Innovative mindset

• Strong understanding of CDISC/Study Data Tabulation Model (SDTM) and corresponding implementation guides, CDISC terminologies and the related regulations for submission deliverables

• Process oriented with Quality Assurance/Quality Control prior experience

• Ability to work under pressure in a changing environment

• Understanding of data management systems and tools and their interactions

• Demonstrated leadership and collaboration skills to establish good working relationship within internal teams and external stakeholders

• Ability to be flexible and work independently.

• Open to new learning opportunities to improve the way we work.

#EligibleforERP

ResearchDivisionGCTO

#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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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Expected salary range:

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):