MSD Clinical Research Manager 

China, Hong Kong, Hong Kong Island 

420377506

Job Description

Job title: Clinical Research Manager

• Be part of a high-performing team to drive strong results for the business and significant impact for customers
• Exciting permanent full-time role based in Hong Kong
• Join the premier biopharmaceutical company that has been in the business for more than 125 years and in Asia Pacific over 60 years

WHAT YOU WILL DO

This role is primarily accountable for the end-to-end performance and project management forrequirements internally and externally.

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, company 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 CRA manager 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 CTC, CRAs and
  COM).
• 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 across clinical trials, countries, clusters.
• Responsible for collaboration with functional outsourcing vendors, investigators, other
  external partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent company with investigators.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts
  and manage budgets).
• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical
  Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions
  across the trials. Consult with GHH as needed.

CORE Competency Expectations:

• Knowledge in Project Management and site management.
• Strong organizational skills with demonstrated success 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 strong understanding of local regulatory environment.
• Strong scientific and clinical research knowledge is required.
• Strong understanding of clinical trial planning, management and metrics is essential as
  well as the ability to focus on multiple deliverables and protocols simultaneously.
• Experience functioning 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 and skills to manage resource allocation, 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.
• Understand cultural diversity.
• The position requires proven strong project management skills and/or project management
  certification or relevant training program/close mentoring.
  

Behavioural Competency Expectations:

• Strong leadership skills that enable and drive alignment with the goals.
• Ability to identify problems, conflicts and opportunities early and lead, analyse 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,

3) performance or compliance issues,

4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations. Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

What we look for …

Current Contingent Workers apply

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