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Merck 2025 University Recruiting - Clinical Trial Data Management Intern in Rahway, New Jersey

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 & Development Division can provide you with great development and a chance to see if we are the right company for your long-term goals.

Our clinical team is recruiting for summer interns within the trial manager area of our company. The Trial Data 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.

  • 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 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 clinical data management procedures. Interacts with staff across multiple our Company sites.

Primary Activities include but are not limited to:

  • Develop 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, biomarker data, and patient reported outcomes.

  • Serve 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.

  • Read and interpret the clinical protocol from a clinical data management perspective.

  • Provide clinical data management input into trial design, as appropriate, ensuring operational feasibility.

  • Engage 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.

  • Ensure appropriate use of standards and project-level consistency of database design, data collection, and validation.

  • Facilitate assessment and processing of standards and change requests.

  • Approve trial-level data validation plan (including project and protocol specific data validation elements).

  • Manage trial-level data quality and completion of database lock and post-database lock activities:

  • Monitor overall status and quality of data being collected during the in-life portion of a trial.

  • Engage with key stakeholders and subject matter experts to refine data management tools and validation plans, as appropriate.

  • Ensure activities required to achieve database lock (or data extraction) are completed by appropriate, responsible functional area.

  • Ensure timely archival of trial data and documentation.

  • Ensure 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.

  • Support site and sponsor audits, as appropriate.

  • Identify and support improvements to data collection and data management processes and tools.

* Note: This position is located in Rahway, NJ or West Point, PA based on candidate preference.

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, on-site, for up to twelve (12) weeks beginning June 2025

  • Candidates must have interest in learning Clinical Data Management

Preferred Experience and Skills:

  • Basic understanding of the clinical research process

  • Strong organization and management skills

  • Ability to communicate effectively (verbal and written), within technical and business areas

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$39,600.00-$105,500.00

FTP2025

MRL2025

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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:

Intern/Co-op (Fixed Term)

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

10/28/2024

*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.

Job Posting End Date: 10/28/2024

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.

Requisition ID: R310697

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