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Upper Gwynedd PA Full Time Posted: Monday, 16 April 2018
 
 
Applicants must be eligible to work in the specified location
Requisition ID: CLI007251

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.
This role is accountable for performance and compliance 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.
Under the oversight of the SCOM/COM manager the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Incumbent will have the ability to work remotely within the United States.

Responsibilities include, but are not limited to:

Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM.
Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
Contributes to the development of local SOPs. Oversees CTCs as applicable.
Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely with Regional Operations and Headquarter to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.
Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
Works closely with the SCOM, COM line manager, and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials in order to support and manage the pipeline and local business needs to agreed timelines and budgets. Required to in/directly influence investigators, external partners and country operations to adhere to budget targets and agreed payment timelines.
Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Qualifications

Core Competency Expectations:

Requires expertise of core clinical systems, tools and metrics
Excellent English skills required
Strong coordination and organizational skills required
Requires skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up.
Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the SCOM or manager.
Ability to make decisions independently with limited oversight from SCOM or manager. Able to manage important activities relevant to clinical research activities in the country according to predetermined global policies and commitments. Requires strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager.
Position requires extensive experience in clinical research operations and experience with project management and coordination.
Expertise of core clinical, regulatory and financial systems, tools, metrics and local requirements is essential.
Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Additionally for financial responsibilities: Background in business finance is preferred and strong knowledge and aptitude in accounting and financial procedures.

Behavioral Competency Expectations:

Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyse root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include: 1) Issues in budget/CTRA negotiations, 2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functional area deliverables that could jeopardize protocol milestones.
Strong communication, leadership, and negotiation skills as well as excellent influencing and training/mentoring skills, both written and verbal, in local language and English.
Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

Experience Requirements:
Required:
5 years of experience in clinical research

Educational Requirements:
Required:
Bachelor's Degree (or comparable) in Business Finance/Administration/Life Science or equivalent Health Care related experience

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 (see below)

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 bedeemed 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.

EEOC Poster
EEOC GINA Supplement

Job: Clinical Research Monitor
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: Merck

Upper Gwynedd PA, United States of America
Healthcare
Merck
Merck
JSCLI007251-EN_US
4/16/2018 9:39:15 AM


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