Lead Clinical Data Manager
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.
Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Merck Standard Operating Procedures (SOPs) and ICH-GCP guidelines. Works with management to maintain the consistent execution of quality global procedures and monitors workload and resource allocation. Supports the comprehensive development of junior staff and encourages effective interaction of Data Management Center (DMC) staff with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of Global Data Operations (GDO) deliverables at the trial level.
Primary activities include, but are not limited to:
- All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager (CDM)
- Accountable for all protocol level start-up, in-life and database lock tasks and activities performed by CDM/SCDM
- Interact and communicate with customers and stakeholders both internal and external to GDMS as well as Merck when needed
- Accountable within GDO to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs)
- Coordinate the execution of user acceptance testing of data management tools
- Provide inputs in to the preparation of the investigator meetings materials, and makes him/her available for questions. May present data management instruction at investigator meetings based on business need and management decision
- Participate in relevant operational meetings to identify and incorporate global operational issues into the study design
- Execute and trigger communications and escalations at the protocol level within department, within function and cross-functionally
- Execute and maintain adherence to a metrics control plan and quality assessment indicators at the trial level
- Coordinate the database lock preparation and monitoring of checks, such as data flow and derivations
- monitoring, for clinical data repository and triage issues according to report output
- Accept and execute special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as developing and delivering programs and materials to instruct staff regarding business processes, leading or participating in cross functional technical improvement projects, etc
- Continually monitor for opportunities to improve efficiency, effectiveness and quality and implement changes as appropriate at the trial level, program level, TA level and GDO Level
- Performs tasks with minimal guidance from manager(s)
- Support and execute any role or task in the team when needed
- At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline
- Five years’ experience in pharmaceutical clinical trial data management
- Knowledge of database structures and available tools to manage, extract, and report data
- Fluent Oral and written English language skills
- Knowledge of applicable regulations and policies
- Proficient overall working knowledge of the clinical development process
- Good working knowledge of clinical practice and medical terminology
- Ability to work cross functionally and as part of a team
- Be able to work under pressure in a changing environment with flexibility
- Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager
- Ability to coordinate the work of others and influence decision making
- Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas
- Exceptional organizational, problem-solving and negotiating skills
- Experience the development of data validation tools
- Training of data management staff
- Demonstrated excellent project management and leadership 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