Associate Clinical Research Manager

Found in: beBee S HK - 4 weeks ago

Hong Kong, Hong Kong SAR China MSD Full time

Job Description

Associate Clinical Research

With support of other CRMs and/or TA-Head/CRD, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally.

The 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, policies and procedures, quality standards and adverse event reporting requirements internally and externally.

o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA-Manager and/or functional vendor and internal management as needed.

o 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 CTCs, CRAs and COMs).

• Responsible for creating and executing a local risk management plan for assigned studies.

• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

• Escalates as needed different challenges and issues to TA-Head/CRD/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 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 HQ functions, regional and local operations, 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.

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 Research Labs (MRL), Global Clinical Development (GCD) and GCTO.

• Ability to identify problems, conflicts, and opportunities early, analyses and prepare mitigation plans and drive conflict resolution is critical.

• Required to negotiate skilfully 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, and 5) resolution of conflictive situations.

• Understand cultural diversity.

• Strong diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders

Education Requirement:

  • Bachelor’s degree in science (or comparable)

Required Experience and Skills:

  • 4+ years of experience in clinical research
  • CRA experience preferred.

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—and start making your impact today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):


Requisition ID:R287994

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