MSD Lead Clinical Data Manager 

Poland, Masovian Voivodeship 

836589894

Job Description

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 Contingent Workers apply

Not Applicable

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

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.