Job Description

Responsibilities:

• Support the Specimen Lifecycle Management for a particular specimen category and/or biorepository.

• Support the Specimen Management Plan development, execution, maintenance, and closure, including but not limited; sample start-up documentation support and review, sample logistics/mapping, sample tracking and monitoring reports, and sample destruction.

• Support the successful execution of the Specimen Management activities in our Company's clinical trials, including but not limited to:

  • Run reports for the Specimen Management Plan for pertinent sample types.

  • Manage the specification documents to support vendor set-up and data transfer planning at a Therapeutic Area/Indication level to support study level implementation

  • Support Specimen Oversight Meetings, as appropriate.

  • Support issue escalations to Associate Director SLM from internal and external stakeholders regarding study specific specimen management issues.

  • Support the Associate Director SLM review of sample retention and destruction; sample destruction agreed upon by internal/external stakeholders.

  • Support specimen management processing and reporting occurs according to plan by utilizing central analytics and monitoring for sample tracking and reconciliation, as well as, testing and reporting progress throughout the lifecycle of a sample.

• Support the development, implementation, and maintenance of an end-to-end Specimen Management Technology solution; support and advocate for continuous improvement of the Specimen Management processes and tools.

• Support the planning and execution of Governance Meetings with key Specimen Management Partnerships and/or participate in other various governance meetings, as needed.

Core Skills:

• Pharmaceutical, research, medical, and/or clinical drug development knowledge/experience

• Strong communication, writing, and presentation skills

• Effective time management and organizational skills

• Ability to effectively work in a team environment and independently

• Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

• Preferred: knowledge of GCP, project management, process improvement, data analytics

Education

• Bachelor's Degree +1 years of pharmaceutical, laboratory and/or project management

• Biospecimen management experience, preferred

#EligibleforERP

ResearchandDevelopmentGCTO

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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:

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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, Monday - 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".

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.

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Relocation:

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Requisition ID:R324372