Clinical Research Manager Job

Employer
Merck
Location
Rahway, NJ, US
Posted
September 15 2017
Discipline
Other
Organization Type
Pharma
Clinical Research Manager-CLI006370

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

The position requires the ability to make decisions independently and oversee important activities relevant to clinical research activities in the country according to predetermined global policies and commitments with the support, oversight and supervision of the Country Research Director. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.

Primary activities/responsibilities include but are not limited to:

- The incumbent is accountable for the performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally.

- The CRM is the country point of contact (POC) for assigned protocols between headquarters and Country Operations and pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments, requiring strong collaboration with local Country Operations roles. The CRM forecasts country resource needs and serves local business needs (signs contracts, manages budgets as delegated).

- The CRM is responsible for quality and compliance for assigned protocols in the country and oversees CRAs and/or Clinical Trial Coordinators (CTCs) and training compliance. Performs quality control visits, reviews Monitoring Visit Reports and escalates performance issues and training needs to functional vendor and internal management as needed.

- The CRM is responsible for collaboration and relationship management with investigators for insourced and outsourced studies, with functional outsourcing vendors and other external partners. The CRM oversees country and site validations, site selection and recruitment in assigned protocols.

- The CRM is responsible for clinical trial education to sites, and acts as the country POC for programmatically outsourced trials for assigned protocols. In collaboration with Clinical Research Director (CRD), represents Merck/MSD in Pharma industry issues and in seeking influence in external R&D environment.

- The CRM collaborates internally with Global Medical Affairs/Global Human Health, local Pharmacovigilance and Regulatory Affairs to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations. The position requires coordination and alignment with the regional and broader organization.

- The ability to identify problems, conflicts and opportunities early and lead, analyses and prepare mitigation plans and drive conflict resolution is critical. The position requires skillful negotiation in tough situations with both internal and external groups; settle differences with minimum noise; win concessions without damaging relationships; be direct and forceful as well as diplomatic; gain trust quickly from other parties in negotiations and have an excellent sense of timing. Examples of common problems include:

- Low patient recruitment

- Inadequate staff to meet business needs

- Performance or compliance issues

- Working with regulatory issues and the broader organization

- Resolution of conflictive situations on country level.

**This is a home based position; incumbent can sit anywhere in US.**

Qualifications

Education:

- Bachelor’s degree or equivalent with a minimum of 8 years of experience in Clinical Research, OR a Master’s degree with a minimum of 6 years of experience in clinical research, OR a PhD/MD with a minimum of 3 years of clinical research experience

Required:

- Knowledge and experience of clinical trial planning, (site) management and metrics

- Strong communication, educational/pedagogic, diplomatic and empathic skills.

- Strong leadership skills (scientific and business) and proven ability to coordinate and lead local teams to high performance.

- Strong organizational skills with demonstrated success required.

- Ability to lead across several dimensions simultaneously.

- Excellent oral and written English language skills.

- Problem solving and conflict resolution

- Negotiation skills with both internal and external groups

- Has demonstrated the following leadership behaviors:

- Ethics & Integrity

- Rapid, Disciplined Decisions

- Focus on Customers

- Courage & Candor

- Drive Results

- Build Talent

- Collaborate

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Clinical Research - Clin Ops

Job Title:Assoc. Dir, Clin. Operations

Primary Location: NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Company Trade Name:Merck

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