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województwo mazowieckie, Polska
Hybrid
Not Available
Job Description
The Lead Clinical Data Manager (LCDM), under the direction of applicable management, is responsible for leading end-to-end clinical data management activities for assigned clinical trials and/or standards initiatives. This role ensures the design, development, validation, maintenance, and delivery of high-quality clinical data management processes and tools in compliance with company Standard Operating Procedures (SOPs), ICH-GCP guidelines, and applicable regulatory requirements.
The LCDM serves as a key point of contact for study-level and standards-level data management activities, provides leadership to junior staff, supports cross-functional collaboration, and contributes to continuous process improvement. The role is accountable for the timely and high-quality execution of deliverables at the trial level and may also be responsible for the quality and maintenance of new or updated eDT/eCRF and associated Data Validation components across Standards Libraries.
Key Responsibilities:
Trial-Level Data Management
Lead all protocol-level start-up, in-life, and database lock activities for assigned studies.
Design, create, validate, review, approve, and maintain data management tool specifications, including:
eCRFs
Time & Events schedules
eCRF entry guidelines
Edit checks
Data Review Plans (DRPs)
In-life reports
Coding/encoding specifications
Data Management Plans (DMPs)
Coordinate and/or participate in user acceptance testing (UAT) for data management tools.
Review data integrity, perform reconciliation activities, and manage query generation, tracking, and resolution.
Coordinate database lock preparation, including monitoring of data flow, derivations, and issue triage based on report outputs.
Support the preparation of investigator meeting materials and respond to study-specific data management questions.
Present data management guidance at investigator meetings when required by business need.
Participate in operational meetings to ensure global operational issues are reflected in study design and execution.
Execute and escalate protocol-level communications within and across functions as needed.
Monitor and maintain adherence to metrics, quality indicators, and control plans at the study level.
Identify opportunities to improve efficiency, quality, and effectiveness and implement approved improvements at the trial, program, TA, or department level.
Perform assigned tasks with minimal management oversight.
Provide support across team roles when needed.
Serve as a primary trainer for new staff, including CDMs, SCDMs, and LCDMs.
Standards-Level Responsibilities
Apply critical thinking, industry knowledge, and technical expertise to recommend efficient and effective Data Validation components at trial and/or standards levels.
Optimize system setup and reconciliation while ensuring quality expectations are met.
Identify and develop opportunities to improve Standards Data Management processes and tools.
Execute quality assurance and quality control activities for the development and maintenance of Data Validation components across Core/Generic and Therapeutic Area libraries.
Participate in Global GCDS/GDMS standards forums and governance discussions, including:
Standards Review Committee (SRC)
GDO TAST Governance & Leadership
Standards Implementation Strategy and Priority Management (SISPM)
Shared Clinical Data Standards Council (SLIC)
Leadership and Collaboration
Work with management to ensure consistent execution of global quality procedures.
Monitor workload and resource allocation when applicable.
Support the development of junior team members through coaching, mentoring, and knowledge sharing.
Build and maintain effective working relationships with internal and external stakeholders.
Influence decision-making and coordinate work across functions to achieve common objectives.
Required Qualifications:
Bachelor’s degree in Life Sciences, Computer Science, Health Care, or related discipline with at least 3 years of professional experience in clinical data management; or
Associate degree with at least 5 years of professional experience in clinical data management; or
High School Diploma or equivalent with at least 8 years of professional experience in clinical data management.
Preferred Knowledge, Skills, and Abilities:
Knowledge of database structures and tools used to manage, extract, and report data.
Strong understanding of applicable regulations, policies, and clinical development processes.
Working knowledge of clinical practice and medical terminology.
Familiarity with CDISC and SDTM standards and implementation guides.
Strong oral and written English communication skills.
Ability to work effectively cross-functionally and as part of a team.
Ability to work under pressure in a changing environment with flexibility.
Ability to work independently with minimal guidance and strong accountability.
Ability to coordinate the work of others and influence decisions.
Excellent communication skills with both technical and business audiences.
Strong organizational, problem-solving, project management, and negotiation skills.
Demonstrated leadership capabilities.
Proficiency in Microsoft Office, especially Microsoft Excel.
What We Offer:
We offer a collaborative and inclusive environment where you can grow your career while making a meaningful impact on global clinical development. As part of our team, you can expect:
The opportunity to work on innovative clinical research and contribute to the development of new therapies.
A highly collaborative, cross-functional environment with exposure to global teams and stakeholders.
Opportunities for professional growth, learning, mentoring, and leadership development.
The ability to influence data quality, process improvement, and standards initiatives at both study and enterprise levels.
A culture that values quality, accountability, teamwork, and continuous improvement.
Access to company-supported tools, systems, and training to help you succeed in your role.
A meaningful role where your expertise directly supports clinical trial success and patient-focused innovation.
Additional Notes:
This role requires a high level of professionalism, attention to detail, and the ability to balance operational execution with strategic improvement. The LCDM is expected to maintain compliance, drive quality, and support team development while contributing to both study execution and standards advancement.
Required Skills:
Clinical Data Management, Clinical Development, Clinical Information Systems, Clinical Operations, Clinical ResearchPreferred Skills:
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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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
YesHazardous Material(s):
n/aJob Posting End Date:
09/25/2026*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.