Clinical Schedule Manager job in Upper Gwynedd
|Employer:|| Merck & Co.|
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. |
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This position reports to the Associate Director, Statistical Programming (SP), within the Biostatistics and Research Decision Sciences (BARDS) organization and is a member of the Global Process and Standards (GPS) team. As a member of the GPS team, the responsibilities of this position contribute to the Statistical Programming department and the overall Quantitative Sciences organization in various ways.
The responsibilities of the candidate include but are not limited to:
• Overall clinical schedule management - design, generation, review, distribution.
• Provide input for Interactive Response Technology requirements and system development.
• Perform activities related to the support of unblinding data analysis.
• Statistical graphics support related to advisory committee meetings, publications, and presentations.
• Ensure compliance for maintaining blinding during study conduct.
• Engage with operational staff and partners globally.
Education Minimum Requirement:
• A minimum of a Bachelor's Degree in Computer Science, Statistics, Life Sciences or related field.
Required Experience and Skills:
• A minimum of five (3) years of pharmaceutical drug development experience.
• Working knowledge of the clinical development process and clinical study design.
• Basic understanding of statistics, clinical, medical monitoring and data management concepts.
• Good understanding of clinical trial randomization, blinding, and unblinding processes and tools.
• Knowledge of data structures and corresponding tools used to manage, extract, analyze, and report data.
• Knowledge of SAS programming and experience with blinding and unblinding of databases.
• Must be able to organize, prioritize, and work efficiently and effectively in a constantly changing environment.
• Ability to function both independently and in a team environment.
• Strong written and oral communication skills.
• Excellent interpersonal skills and ability to collaborate effectively.
Preferred Experience and Skills:
• Knowledge in developing and updating clinical randomization and component ID schedules and related processes for clinical trials.
• Understanding of Interactive Response Technology development.
• Knowledge of System Development Life Cycle and experience performing system User Acceptance Testing (UAT).
• Knowledge in development of Analysis and Reporting deliverables for Research & Development projects.
• Experience reviewing, writing, editing, and maintaining documentation.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to email@example.com .
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Visa sponsorship is not available for this position.
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