Associate Director, Regional Clinical Project Manager (RCPM) Job

Associate Director, Regional Clinical Project Manager (RCPM)-CLI004966

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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


The Regional Clinical Project Manager (RCPM) is a key role to ensure successful execution of clinical trials in the Americas. The RCPM has a significant impact on the ability to effectively conduct clinical studies and develop the pipeline, while meeting regulatory and compliance requirements. The position directly impacts the region's ability to reach commitments, targets and objectives and build project teams across countries in the region.

The position is responsible for project deliverables and performance in assigned therapeutic areas and/or geographic area within the region. The RCPM is the primary point of contact between Headquarters (HQ) and Country Operations and develops understanding of country requirements to proactively serve and coordinate country needs. The RCPM partners closely with HQ functional areas and builds meaningful relationships and networks across the organization.

Primary activities/responsibilities include but are not limited to:

- Responsible for protocol related targets, objectives and commitments regionally.
- Leads protocol teams to high performance; supports and interacts directly with CRAs to manage site level activities, interacts and communicates closely with CRM and COM for country timelines and deliverables, and escalates appropriately to CRD to drive efficient study start up, trial execution and closeout across the region. Example of liaising with stakeholders could be; Site selection activities including coordination of site identification, evaluation & validation, in coordination with CRAs and country management. Coordinates validation activities across all involved countries. Work with country data to ensure a feasible and competitive regional proposal. Works with country managements to ensure countries deliverables are ready on time.
- Responsible for meeting regional targets and objectives for assigned protocols. Drives and tracks protocol deliverables, timelines, trends and performance to meet regional commitments in partnership with countries. It is critical the RCPM manages trials proactively; identifies risks and opportunities early and lead, analyze and prepare mitigation plans and escalate to management. Examples of common problems include 1) low patient recruitment, 2) inadequate sponsor staff to meet business needs, 3) compliance issues and poor study quality, 4) regulatory issues, 5) availability of clinical supplies, and 6) issues related to functional area deliverables that could jeopardize protocol milestones
- Must make decisions independently to ensure trials are successful and executed in a compliant and timely manner, with support from regional leadership for key decisions (e.g. change allocation of patients in the region) to ensure regional commitments are met. Provides input to shape regional strategy
- Acts as primary point of contact between HQ and country operations in trial coordination and communication. Partners closely with HQ functional areas and builds meaningful relationships and networks. Requires careful coordination and alignment with the regional and broader organization.
- Interacts and communicates effectively in a culturally diverse remote virtual environment. Facilitates protocol-specific information sharing and best practices across countries. Provides protocol related training and expertise in the region.
- Coordinates protocol related HQ documents and oversees availability of HQ deliverables and supplies for countries. Collates CTA and other submission documents for the region as applicable. Updates and monitors clinical trial related systems and other protocol tracking tools as needed. Coordinates investigator's meeting activities.
- Builds a collaboration spirit in a virtual environment and across countries, cultures and functions.

This is a home-based/remote position.

Qualifications

Education:

- Required: Minimum Bachelor's degree in Science or Health Care
- Desired: Master of Science or Medicine. Advanced degree (PhD)

Required:

- Minimum 8 years of clinical research experience.
- Extensive project management experience.
- Expert operational knowledge of how clinical trials are conducted and strong scientific operational understanding.
- The position requires the ability to follow established processes and protocols and coordinate effectively with internal and external stakeholders.
- Proven extensive experience with project management with demonstrated success required. International experience will be valued.
- Excellent communication, educational/pedagogic, interaction, collaboration and organizational skills
- Strong ability to lead and coordinate protocol teams to high performance across the region. Requires that the individual has ability to work with a wide range of people across countries in a culturally diverse and remote virtual environment
- Requires robust team building spirit with country operations.
- Ability to proactively develop risk management and mitigation plans across the region in an autonomous way to secure study success.
- Expertise in core systems and metrics. Requires ability to focus on multiple deliverables and protocols simultaneously.
- Ability to lead across several dimensions simultaneously.
- Ability to build understanding of country requirements to proactively serve and coordinate country needs specifically during study start up.
- Working knowledge of Merck’s core business structure and how own function contributes to and works within the organization
- Strong influencing skills
- Ability to think strategically
- Relationship management and networking: strong integration into headquarter network and ability to build productive relationships with all parties
- Ability to prioritize, align and simplify
- Fluency in English is required
- Fluency in Spanish, French or Portuguese is desirable
- Has demonstrated the following leadership behaviors:
- Ethics & Integrity
- Rapid, Disciplined Decisions
- Focus on Customers and Patients
- Courage and Candor
- Drive Results
- Build Talent

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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:Associate Director, Clinical Operations

Primary Location: NA-US-NJ-Rahway

Other Locations: NA-US-Kentucky, NA-United States, NA-US-Idaho, NA-US-Massachusetts, NA-US-North Dakota, NA-US-Nebraska, NA-US-North Carolina, NA-US-Vermont, NA-US-Alaska, NA-US-Virginia, NA-US-Alabama, NA-US-Kansas, NA-US-Utah, NA-US-Arkansas, NA-US-Georgia, NA-US-Arizona, NA-US-Connecticut, NA-US-Maryland, NA-US-New Jersey, NA-US-Mississippi, NA-Canada, NA-US-Delaware, NA-US-Indiana, NA-US-Missouri, NA-US-Wyoming, NA-US-Oklahoma, NA-US-West Virginia, NA-US-New York, NA-US-Louisiana, NA-US-New Mexico, NA-US-PA-Upper Gwynedd, NA-US-New Hampshire, NA-US-Colorado, NA-US-Hawaii, NA-US-Oregon, NA-US-Texas, NA-US-Ohio, NA-US-Illinois, NA-US-Maine, NA-US-Washington, NA-US-Iowa, NA-US-Rhode Island, NA-US-California, NA-US-Nevada, NA-US-Michigan, NA-US-Wisconsin, NA-US-South Dakota, NA-US-Tennessee, NA-US-Florida, NA-US-District of Columbia, NA-US-Montana, NA-US-Pennsylvania, NA-US-Minnesota, NA-US-South Carolina

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Company Trade Name:Merck