Study Manager - Immunology

Job Summary

This position contributes to the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to develop your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.

Job Responsibilities

• May be responsible for tracking study timelines using project management tools.
• Shares technical expertise with team members.
• May interact with internal and external stakeholders (e.g., study team, vendors, committees) in support of clinical trial objectives.
• May have specific operational responsibilities for a single study or across multiple studies (e.g., operational deliverables, clinical & ancillary supplies planning/tracking, lab specimen tracking, status update reports, study closeout activities).

Core Skills

• Working knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
• Interact with key stakeholders across department, division, and company. Role requires a proactive approach driving toward study goals.
• Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)
• Building analytical skills to drive operational milestones
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Good understanding of the principles of project planning & project management
• Solid communication, writing, and presentation skills

Experience

Bachelor’s degree + 2 years or Master’s + 1 year Pharmaceutical and/or clinical drug development experience. Degree in life sciences, preferred.

Ideal candidate would have:

• Experience in conducting clinical trials in GI, rheumatologic and/or dermatologic disorders preferably autoimmune/immune mediated disease trials.
• Experience in supporting the conduct of global clinical trials, including trial initiation through database lock.

Candidates with the following experiences/expertise are preferred, but not required:

• Working on a team environment supporting clinical trial
• Supporting trial leads with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.

MRLGCTO

#eligibleforERP

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CSSMGenMed

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 separationpackage, 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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U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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:

$88,480.00 - $139,100.00

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.

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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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid, Remote Work

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R252450