Senior Specialist, Clinical Data Management Early Development (EDEV) Lead Job - United States
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 125-year legacy. 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.
Under the direction of the Associate Director/Manager and Associate Director/Project Data Manager (PDM), the Early Development (EDEV) Leads’ primary focus is data management-related activities in support of Early Development Phase I studies. The EDEV Lead is responsible for executing end-to-end data management activities pertaining to clinical trials, including but not limited to: data management system design, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation, in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines.
Primary activities include, but are not limited to:
- Prepares and delivers the Electronic Data Capture (EDC) system and data review specifications
- Prepares and delivers the study specific data management site training materials
- Manages and performs data integrity review activities
- Serves as the main contact for resolving in-life data issues
- Manages and performs the database lock and archiving activities
- Is aware of, and adheres to, the project timelines
- Identifies project risks and suggests mitigations
- May mentor new hires and other EDEV personnel
- May act as a Subject Matter Expert (SME) within the EDEV team
- Confirms that appropriate documentation is available for assigned studies and adheres to good documentation practices
- Is compliant with GDMS SOPs and training requirements
- May support or lead any other projects/initiatives or perform any other data management tasks deemed appropriate by management
- B.A. or B.S. degree, preferably in life science, computer science or other health care related discipline.
- Minimum 5 years experience in Clinical Data Management, database design/development or related industry experience.
1. Knowledge of database structures and available tools to manage, extract, and report data is preferred
2. Proficient knowledge of the clinical development process, ICH and GCP guidelines
3. Excellent written and verbal communication skills with the ability to communicate with both the technical and business areas
4. Strong organizational, time management and project management skills
5. Ability to present in a group environment
6. Ability to establish and maintain good working relationships with the different functional areas and work cross functionally as part of a team
7. Ability to work under pressure in a changing environment with flexibility
8. Ability to multi-task, work independently, and act with appropriate accountability with minimal guidance by a manager
9. Display a sense of urgency and customer-focus
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 an accommodation for the application process please email us at email@example.com.
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Job: Clinical Data Management
Job Title:Sr. Spclst, Clinical Data Mgmt
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-West Point
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: New York City
Nearest Secondary Market: Newark
Job Segment: Clinic, Database, Medical, Manager, Data Management, Technology, Healthcare, Management, Data