Other responsibilities include:

• Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
• Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
• Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
• Providing tactical/scientific mentorship to other clinical scientist.

Core Skills

• Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills
• Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusion
• Interact with key stakeholders across department, division, and company.
• Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
• Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Build team capabilities through proactive coaching
• Strong communication, technical writing, and presentation skills

Experience

• Bachelor's degree + 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• Master's + 3 years of pharmaceutical, clinical drug development, project management, and/or medical field experience
• PhD / PharmD.
• Degree in life sciences, preferred.

Ideal candidate would have

• Experience in conducting global clinical trials, including trial initiation through database lock.
• Experience in conducting clinical trials in gastrointestinal, rheumatologic and/or dermatologic disorders preferably autoimmune/immune mediated disease trials.
• Experience with external expert review of participant eligibility (e.g., QC inclusion and exclusion criteria)

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

• Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
• Managing other scientists directly supporting the clinical trial

ResearchGCTO

#eligibleforERP

CSSMgenmed

CSSMhiring

Current Employees apply HERE

Current Contingent Workers apply HERE

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 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:

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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, 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".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:
$111,400.00 - $175,300.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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:
No

Hazardous Material(s):
n/a

Job Posting End Date:
11/2/2024
*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:R317023