Program Manager, Clinical Database Services
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.
Oversees and coordinates clinical database activities for clinical programs including the review of electronic Case Report Forms, edit check specifications, and database development. Ensures adherence to clinical database standards, SOPs and Process Guidelines. Plans appropriately to ensure adherence to timelines for all clinical database services deliverables and escalate risks to management. Interface with members of study teams to integrate study team requirements into all deliverables. Interface with Clinical Database Services (CDS) manager/supervisor to assure consistency of technical and process strategies. Aligns others around a positive direction. Develops challenging but achievable objectives that clearly support stated organizational goals. Interacts and communicates clinical database processes and requirements to external vendors.
Leads and participates in extra activities including, but not limited to, improvement task forces, automations, testing of new systems and helps coordinate CDS technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group. Provides ongoing clinical database support to other departments. When necessary, may perform development activities such as database development or Peer Review.
Provides oversight to Clinical Database Developers. Participates in the recruitment process, mentoring and training of new hires and ongoing technical development of Clinical Database Developers. Provides input into the performance appraisals of Clinical Database Developers to management. Ensures the adherence to standards in the development, documentation and maintenance of data dictionaries.
If technically trained, performs as a Subject Matter Experts (SME) of clinical database and Electronic Data Capture activities including the creation of clinical databases and data transfer files. Increases functional effectiveness by supporting departmental efforts to simplify and standardize procedures to the greatest extent possible, sharing best practices and leading continuous improvement efforts.
Conducts management and functional area meetings, contributing expertise when necessary through formal or informal presentations.
- Bachelor’s degree in computer science or life sciences software design, procedure language, development theory and techniques, testing methodologies, and software documentation.
- Experience in software design, procedure language, development theory and techniques, testing methodologies, and software documentation
- Minimum of 5 years pharmaceutical experience within clinical research
- Experience in technology acquisition and implementation
- 1-2 year project management experience (either one project for a year or multiple project totaling 1 year)
- Demonstrates a high level of understanding with the design and development of electronic Case Report Forms (eCRFs), clinical databases and other methods of capturing and transferring data, clinical database development tools, standards and the development process in support of clinical research.
- Knowledge of Electronic Data Capture Systems or Data Management Systems
- Solid knowledge of MS Windows/Office software and exposure to web based applications.
- Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning process, and 21 CFR Part 11.
- Ability to establish and maintain good working relationships with different functional areas.
- Strong sense of urgency and customer focus.
- Possesses excellent communication skills and interacts effectively with Study Team.
- Strong organizational, time management, and multi-project coordination skills
- Broad knowledge of Clinical Development and Regulatory Affairs requirements
- Ability to multi-task, work independently, and good communication skills
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.
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Job: Clinical Data Management
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck