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 applicable management, the Manual Encoding Lead (ME Lead) is responsible for executing end to end data management activities pertaining to the encoding of clinical trial data, 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 GDO staff with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of Global Data Operations (GDO) deliverables related to encoding at the trial and program level.
Primary activities include, but are not limited to:
- All activities of an Encoder.
- Accountable for all encoding related protocol level start-up, in-life and database lock tasks and activities performed by all coding staff at the trial level.
- 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 encoding specifications as needed.
- Coordinate the execution of user acceptance testing of encoding as needed.
- Participate in relevant operational meetings.
- 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 activities related to encoding and triage and track issues to resolution.
- 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).
- Serve as subject matter expert for encoding processes, globally and locally, at the trial level, program level and TA Level.
- B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline
1. Five years’ experience in Pharmaceutical Encoding and/or Vocabulary Management.
2. Excellent Oral and written English language skills.
3. Knowledge of regulations and policies applicable to the pharmaceutical industry encoding.
4. Proficient overall working knowledge of the clinical development process and the value of encoding.
5. Excellent working knowledge of clinical practice and medical terminology.
Preferred Experience and Skills:
1. Ability to work cross functionally and as part of a team.
2. Be able to work under pressure in a changing environment with flexibility.
3. Ability to work independently and accept and act with appropriate accountability with minimal guidance by a manager.
4. Ability to coordinate the work of others and influence decision making.
5. Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
6. Exceptional organizational, problem-solving and negotiating skills.
7. 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
Job Title:Sr. Spclst, Clinical Data Mgmt
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
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: Philadelphia
Job Segment: Medical, Pharmaceutical, Pharmacy, Data Management, Healthcare, Science, Research, Data