Global Clinical Data Standards Therapeutic Area Lead
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 our Company guidelines and SOPs.
- Able to work independently or as a team member with equal effectiveness. Interacts with staff across multiple our Company sites
B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline; or 8 years of relevant 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
Analysis & Reporting experience
Program-level clinical and business requirements knowledge
Must have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects. Knowledge of clinical data management.
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.
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Under New York City, Washington State and California State 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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Flexible Work Arrangements:Remote Work
Shift:1st - Day
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Number of Openings:2