Clinical Trial Specialist, Translational Medicine

Job Description

Position Description

Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late-stage Clinical Research across all therapeutic areas. Our team is focused on innovation and dedicated to translating breakthrough science into innovative medicines that extend and improve the lives of patients worldwide. Through clinical trials, we ensure the safety and efficacy of our pipeline and existing products to produce safe, effective, innovative medicine.

The Clinical Trial Specialist partners with the early development clinical study team in the planning, execution, closeout and reporting activities for clinical trials and is accountable for delivering selected critical-to-quality tasks.

Primary Responsibilities

Focus on compliance, quality, timeliness and accuracy of trial and program deliverables, leveraging clinical expertise, project management and communication skills to ensure compliant, accurate and timely reporting (eg, milestone dates in the Clinical Trial Management System (CTMS), Trial Master File (TMF), Clinical Study Reports (CSR))Partner with clinical team for site/CRO ready (planning) through trial closeout and reporting deliverables, including the following activities:Collection/approval of essential documentsSystems provisioning and milestone data entryDrug and ancillary supplies managementClinical Study Report assembly, accuracy and quality control reviewsEnsure timely and complete execution of trial level agreements and contracts (Confidentiality Disclosure Agreements (CDAs), consultant, vendors, trial level samples and services)Contribute to inspection readiness with expertise and knowledge of global/local regulations, GCP, and ICH guidelinesDetect and resolve quality issues, escalating to clinical scientist or consulting other functions (eg, Quality, Legal, Compliance, etc.) to arrive at the best solutionReport, manage, and interpret information for clinical trials to ensure completeness and accuracy across multiple business systems and tools (ESTAR-Early Stage Trial Tracking & Reporting, TMF, CTMS, REDS)

Position Qualifications

Education Minimum Requirement

Bachelor’s degree in Life Sciences and minimum 4 years related experience, OR Master’s degree in Life Sciences and minimum 3 years related experienceeg, knowledge of clinical trial management and trial execution; experience in health-related, life science or analytical related field with experience managing cross-functional teams and projects

Required Experience And Skills

Knowledge of GCP, ICH guidelines, and regulatory requirementsKnowledge of drug development and clinical trial processes, including related standards and documentsAbility to partner effectively with internal and external teams to achieve resultsStrong team collaboration, leadership, and communication (written and verbal) skillsAbility to identify issues and develop mitigation plansAbility to manage/track milestones and deliverables for multiple projects at a time

Preferred Experience And Skills

Global Phase 1 clinical trials experience

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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.

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About

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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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.

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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, 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”.

Under New York State, 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

$83,100.00 - $130,900.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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

Hybrid

Shift

Not Indicated

Valid Driving License

Yes

Hazardous Material(s)

NA

Requisition ID:R290886