Associate Clinical Research Manager, Immunology, Remote

Job Description

With support of other Clinical Research Manager's (CRMs) and/or Therapeutic Area Head (TAH) / Clinical Research Director (CRD), this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with International Council for Harmonisation Good Clinical Practice (ICH-GCP) and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The Associate Clinical Research Manager (aCRM) could be responsible for a particular study for a country or a cluster.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate Manager (CRAM) and/or functional vendor and internal management as needed.
• Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the Clinical Trial Coordinators (CTC), Clinical Research Associates' (CRAs) and Clinical Operations Managers (COMs).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF) and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA-Head/CRD/ Country Clinical Quality Manager (CCQM) and or CTT (as appropriate).
• Identifies and shares best practices.
• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
• As a customer-facing role, this position will build business relationships and represent our company with investigators.
• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TA-Head and Regional Operations.
• Collaborates internally with Headquarters (HQ) functions, regional and local operations, European Union (EU) Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.

Extent of Travel: Up to 30% of working time.

Qualifications, Skills & Experience

Skills:

• Knowledge in Project Management and/or site management.
• Strong organizational skills with demonstrated success in related role or discipline required.
• Requires ability to make decisions independently and oversee important 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
• Requires understanding of local regulatory environment.
• Scientific and clinical research knowledge is required.
• Understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Ability to function as a key link between Country Operations and Clinical Trial Teams
• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.
• Ability to manage processes (and controls), productivity, quality and project delivery.
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking.
• Ability to work efficiently in a remote and virtual environment.
• Aptitude for building leadership skills that enable and drive alignment with the goals, purpose and mission of our Research & Development Division, Global Clinical Development (GCD) and Global Clinical Trial Operations (GCTO).
• Ability to identify problems, conflicts and opportunities early, analyses and prepare mitigation plans and drive conflict resolution is critical.
• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption.
  • Examples of common problems include:
    • 1) low patient recruitment
    • 2) inadequate staff to meet business needs
    • 3) performance or compliance issues
    • 4) resolution of conflictive situations.
• Understand cultural differences.
• Strong diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Qualification & Experience:

• Bachelor’s degree in science (or comparable)
• 4+ years of experience in clinical research
• CRA experience preferred
• Immunology experience preferred

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Required Skills:

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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. 

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