Job Description
The Senior Specialist, Specimen Management & Lab Start-Up is responsible for executing and independently managing key laboratory start-up and specimen management activities across clinical trials. This role ensures that study-specific laboratory requirements are effectively implemented and that biospecimen collection, processing, shipment, tracking, and reconciliation are conducted in a compliant, timely, and high-quality manner.
The Senior Specialist acts as a subject matter resource for study teams and supports cross-functional alignment with internal stakeholders, central and specialty laboratories, and logistics providers to ensure successful study activation and execution.
Key Responsibilities:
Study Start-Up Execution:
- Lead and execute laboratory start-up activities for assigned studies, including:
- Reviewing protocols for specimen requirements and operational feasibility
- Supporting or leading lab feasibility assessments
- Coordinating central and specialty lab set-up
- Contributing to or reviewing lab manuals and study documents
- Supporting sample kit design, forecasting, and distribution
- Ensuring requisition forms and workflows align with protocol requirements
- Track and manage lab start-up timelines and deliverables for assigned studies.
- Identify risks impacting study start-up and escalate or mitigate as appropriate.
Specimen Management Operations:
- Manage end-to-end specimen lifecycle activities, including:
- Sample collection guidance and issue resolution
- Shipment coordination and tracking
- Sample receipt confirmation and chain of custody
- Specimen reconciliation and discrepancy follow-up
- Monitor specimen data for accuracy, completeness, and compliance.
- Investigate and resolve sample-related issues with sites, labs, and providers.
- Ensure high-quality sample handling across multiple sites and studies.
Provider and Laboratory Coordination:
- Serve as a key point of contact for:
- Central laboratories
- Specialty labs
- Logistics and courier providers
- Coordinate kit shipments, lab readiness, and issue resolution.
- Monitor provider deliverables and escalate performance concerns when needed.
- Ensure providers adhere to protocol-specific requirements and timelines.
Cross-Functional Collaboration:
- Partner with Clinical Operations study teams, Biomarker Managers, Pharmacokinetics, Data management, Quality and Regional teams
- Communicate specimen-related updates, risks, and issues.
- Support alignment of specimen processes with overall study execution plans.
- Provide input into study planning and operational readiness discussions.
Quality and Compliance:
- Ensure all specimen management activities comply with:
- Good Clinical Practice (GCP)
- IATA/DOT shipping regulations
- Internal SOPs and quality standards
- Support audit and inspection readiness activities.
- Document deviations and support root cause analysis and corrective actions.
Documentation and Systems:
- Maintain accurate documentation related to:
- Lab start-up activities
- Specimen tracking and reconciliation
- Provider communications
- Utilize systems such as:
- CTMS
- Sample tracking platforms or LIMS
- eRequisition tools (if applicable)
- Generate reports and metrics on specimen performance and study readiness.
Process Improvement:
- Identify opportunities to improve workflows, reduce errors, and enhance efficiency.
- Support implementation of new tools, technologies, or best practices.
- Contribute to standardization efforts across studies and programs.
Mentorship / Leadership Contributions (Informal):
- Provide guidance and support to junior specialists or new team members.
- Share best practices and lessons learned across the team.
- May lead small initiatives or workstreams within broader programs.
Education:
- Bachelor's Degree required
Experience & Skills:
Candidate to have proven experience in:
- Good communication, organizational, and analytical skills
- Ability to oversee specimen analysis and effectively summarize and present insights
- Microsoft office skilled (e.g., excel and power point)
Preferred Experience & Skills:
- At least one (1) year of laboratory, biopharmaceutical and/or the supplier industry experience
Required Skills:
Clinical Research, Clinical Systems, Clinical Trial Management, Good Clinical Practice (GCP), Laboratory Operations, Personal Initiative, Process Improvements, Project Management, Risk Management, Schedule Management, Stakeholder Communications, Test Lab Management
Preferred Skills:
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Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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The salary range for this role is
$106,200.00 - $167,200.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
07/29/2026
*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. 
