Job Description

Job Description

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our Company has codified its legacy for over a century. Our Company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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

This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our Company policies and procedures, and with quality standards internally and externally. The person has ownership, oversight, and impact on local regulatory compliance and for out-tasking as applicable. Under the oversight of the Clinical Operations Manager (COM) manager, the person is accountable to manage/oversee a team of COMs.

Responsibilities include, but are not limited to:

Has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up:

COUNTRY SUBMISSIONS & LOCAL LANGUAGE MATERIALS:

* Accountable for execution and oversight of clinical trial country submissions and approvals for assigned protocols, development of local language materials including local language Informed Consents and translations.

* Works in partnership with IRB / IEC and Regulatory Authority in submission and approval-related interactions for assigned protocols.

MANAGEMENT & QUALITY OVERSIGHT:

* Responsible for managing country deliverables, timelines, and results in assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in the country.

* Contributes to the development of local/Int'l SOPs.

* Oversees partner workers and local vendors (i.e. Central IRB) and will manage employee COMs (10 employees).

COLLABORATION:

* Works with minimal oversight from CRD or COM manager in close collaboration internally with GCTO Country Operations (CRM, CTC, CRA, COM and CQM ), Medical Affairs, PV , Regulatory Affairs, Business Compliance, Research Laboratories departments, legal, HQ functional areas and externally with vendors and sites to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.

* Collaborates closely with Regional Operations and/or Headquarters to align country timelines for assigned protocols.

* Provides support and oversight to local vendors as applicable.

LOCAL PROCESS OVERSIGHT:

* Oversight and coordination of local processes; clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, insurance process management.

* Enters and updates country information in clinical, regulatory, and safety systems.

CORE Competency Expectations:

* Demonstrates proactive leadership and must be able to in/directly influence investigators, vendors, external partners and country managers to deliver these commitments within specified timelines and budgets, with minimal oversight from the line manager.

* Skilled knowledge of the Institutional Review Boards (IRBs), legislation and regulatory environment and submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables.

* Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally. He/she is an independent decisionmaker with a clear comprehension of the pros and cons of each decision and takes ownership of decisions

* Extensive experience with clinical project management and coordination.

* Expertise of core clinical, regulatory systems, tools and metrics.

* Extensive knowledge of local regulatory environment and submission and approval processes. Strong coordination and organizational skills.

* Demonstrates leadership behaviors.

Behavioral Competency Expectations:

* Problem-solving and Process Improvement is essential to this position.

* Ability to proactively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include:

1) Issues in ICF negotiations

2) Quality and compliance issues

3) Regulatory and legal issues

4) issues related to functional area deliverables that could jeopardize protocol milestones

* Strong communication and leadership skills.

* Strong negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal.

* People management skills (also across countries) will be valued.

* The ability to focus on multiple deliverables and protocols simultaneously is essential

* Ability to work effectively also in a remote virtual environment with a wide range of people and understanding of cultural differences.

* Fluency in both English and local language.

Education Minimum Requirement:

* A Bachelor's Degree required

Preferred:

* Master's Degree in Business / Administration/ Life Science or equivalent Health Care related field

Required Experience and Skills:

* 8 years of experience in clinical research

Preferred Experience and Skills:

* Line Manager experience

* Study start-up experience in US country operations ICF (Informed Consent Form) negotiations experience

* Project Management experience

* Experience managing in a matrix environment

*** This is a remote opportunity ***

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

Residents of Colorado

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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.

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.
For more information about personal rights under Equal Employment Opportunity, 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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Domestic

VISA Sponsorship:

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R103759