Job Description

Clinical Research Manager

Opportunity to join a leading global biopharma company

Exciting chance to work with passionate and collaborative teams

Be at the center of innovation and excellence in execution.

Our Clinical Research and Pharmacovigilance team pushes global healthcare boundaries through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Reporting to the Clinical Research Director, you will be primarily accountable for the end-to-end performance and project management for assigned protocols in a country. You could be responsible for a particular study for several countries in a cluster.

What will you do in this role:

You will be the Main Point of Contact (POC) for assigned protocols and links between Country Operations and the clinical trial team (CTT), responsible for project management of the assigned studies.

You will review Monitoring Visits Reports. Escalate performance issues and training needs to CRA manager, functional vendor, and internal management as needed. Performs Quality control visits as required.

You will lead local study teams to high performance: train in the protocol, closely collaborate with and support CRAs as protocol experts.

You will be responsible for creating and executing a local risk management plan for assigned studies. You will ensure compliance with key systems in assigned studies. Escalate as needed different challenges and issues to the Therapeutic Area Head/CRD/CCQM / CTT (as appropriate).

You will collaborate with functional outsourcing vendors, investigators, other external partners in assigned studies. Be country POC for programmatically outsourced trials for assigned protocols.

As a customer-facing role, you will build business relationships and represent the company to investigators. Serve local business needs as applicable in your country (if delegated, sign contracts, and manage budgets).

You will support local and regional strategy development consistent with long\xe2\x80\x90term corporate needs in conjunction with CRD, TAH, and Regional Operations.

You will collaborate internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues and decisions across the trials.

What should you have:

You have a Bachelor degree in Science (or comparable) with a minimum of 5-6 years of experience in clinical research (CRA Experience preferred)

You are an expert in project management with project management certification or relevant training program. You are excellent in site management with strong organizational skills.

You can make decisions independently and oversee essential activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight, and supervision of the TA Head or CRD

You should have experience in the local regulatory environment, scientific and clinical research knowledge, a strong understanding of clinical trial planning, and the ability to multitask on various deliverables and protocols simultaneously.

You should have excellent communication (written and verbal) skills to effectively build a collaboration spirit in a remote/virtual environment and across countries, cultures, and functions.

You have expert-level experience and the ability to manage resource allocation, processes, productivity, quality, and project delivery.

You are a strategic thinker with strong leadership skills and a great understanding of cultural diversity. You can identify problems, conflicts, and opportunities early to lead, analyze, prepare mitigation plans, and drive conflict resolution.

You are experienced in skillfully negotiating challenging situations with both internal and external groups.

This role might require traveling of up to 30% of working time

Who we are:

We are known as Merck & Co., Inc., Rahway, 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 \xe2\x80\xa6

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today.

Current Employees apply

Current Contingent Workers apply

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

Merck & Co.