Lead Clinical Data Manager

Job Description

Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities. 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.

What You’ll Do:

• 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 our Company 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 cTrinning ross-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.

You should apply if you have:

• At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
• Four years’ experience in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required.
• Knowledge of database structures and available tools to manage, extract, and report data is preferred.
• 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.
• Demonstrated excellent project management and leadership skills.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/12/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.