Lead Clinical Data Manager

Job Description

MSD Polska Sp. z o.o. – Inventing For Life  Warsaw, Mazowieckie, Poland On-site 1 day ago  2 applicants

• Full-time
• 201-500 employees · Pharmaceutical Manufacturing

About the job

Job Description

Position Overview

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 the 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 when needed.
• Accountable within GDO to design, create, validate, review, approve and maintain data management tool specifications.
• 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 considerations 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 data integrity issues. Assess risks, setup and execute mitigation plans.
• 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, quality and implement changes as appropriate at the process level, 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.

Education

• At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Knowledge And Skills

• 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.

Who We Are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What We Look For …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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

No relocation

VISA Sponsorship

Travel Requirements

Flexible Work Arrangements

Shift

Valid Driving License

Hazardous Material(s)

Requisition ID R223446