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Rahway, New Jersey, United States
Hybrid
Job Description
The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Research Lab Division can provide you with great development and a chance to see if we are the right company for your long-term goals.
The Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock, archiving, and submission deliverables where applicable. Collaborates with appropriate functional areas to align resources and ensure all aspects of the project plan are executed on time and with appropriate quality. Agrees/arbitrates deliverable-based commitments based on detailed knowledge of trial complexity and requirements. Manages change, customer, and stakeholder expectations, facilitates cross-functional decision making, and performs risk management. Represents functional areas and Global Data Management on cross-functional trial teams and in other trial-level development forums.
Under the guidance of more senior staff, may serve as the data management lead or perform a support role for filing programs. Participates in the development of, and ensures adherence to, our company's clinical data management procedures. Interacts with staff across sites, countries, and time zones.
Primary activities include but are not limited to:
Develops detailed project plans for the collection, review, and cleaning of all clinical data for assigned trials within a specific drug / vaccine program. Data includes, but is not limited to, case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.
Serves as project manager of all clinical data management activities for trials as assigned. Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to perform and manage the following tasks:
Project planning, initiation, execution, change control, and closing.
Project team development, project team leadership, meeting management, and resource coordination.
Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
Management of customer / stakeholder expectations; facilitation of cross-functional decisions.
Defines trial-level requirements for quality data collection and validation at the trial level.
Reads and interprets the clinical protocol from a clinical data management perspective.
Provides clinical data management input into trial design, as appropriate, ensuring operational feasibility.
Engages with key stakeholders and subject matter experts to assess complexity, define trial-level data management requirements and inputs (including timing), and confirm all data management deliverables and services required for a trial.
Ensures appropriate use of standards and project-level consistency of database design, data collection, and validation.
Facilitates assessment and processing of standards and change requests.
Approves trial-level data validation plan (including project and protocol specific data validation elements).
Manages trial-level data quality and completion of database lock and post-database lock activities:
Monitors overall status and quality of data being collected during the in-life portion of a trial.
Engages with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.
Ensures activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.
Ensures timely archival of trial data and documentation.
Ensures timely decommissioning of clinical data management technologies.
Accountable for ensuring the successful execution of delivery of data management services provided by external partners engaged for outsourced trials, as assigned
Supports site and sponsor audits, as appropriate
Identifies and supports improvements to data collection and data management processes and tools.
Required Education and Skills:
Candidate must be working towards completion of a B.A. or B.S. degree in life sciences, computer science or related discipline
Candidates must be available to work full-time for up to twelve (12) weeks beginning June 2027
Candidates must have interest in learning Clinical Data Management
Preferred Knowledge and Skills:
Basic understanding of the clinical research process for Clinical Data Management lifecycle.
Familiar and comfortable with database concepts and tools to manage, extract, and report data.
Strong organization, leadership, and management skills.
Exceptional communication skills (oral and written) with the ability to communicate with both the technical and business areas.
Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company.
Salary range:
The salary range for this role is $39,908 - $111,111 USD.
FTP2027
RL2027
Required Skills:
Preferred Skills:
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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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:
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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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
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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:
Intern/Co-op (Fixed Term)Relocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
10/9/2026*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.
