MSD Manager CRM GCTO 

China, Beijing, Huairou District 

292392236

Job Description

This role is primarily accountable for the end-to-end performance and project management forpolicies and procedures, quality standards and adverse event reportingrequirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

Main Point of Contact (POC) for assigned protocols and link between Country Operations

Responsible for project management of the assigned studies: protracks execution and performance of deliverables/timelines/results to meet country

Accountable for performance for assigned protocols in a countryadverse event reporting requirements internally and externally.

- Reviews Monitoring Visits Reports and escalates performance issues and trainingneeds to CRA manager and/or functional vendor and internal management as

Performs Quality control visits as required.

different local country roles ensuring a strong collaboration (including the CTC, CRAs and

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).

external partners in assigned studies.

Country POC for programmatically outsourced trials for assigned protocols.

with investigators

in his/her country (if delegated can sign contractsand manage budgets).

Supports local and regional strategy development consistent with longterm corporate needsin conjunction with CRD, TAH and Regional Operations.

, regional and local operations, EU ClinicalDevelopment, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions

CORE Competency Expectations:

Knowledge in Projectand site management

Strong organizational skills with demonstrated success required.

Requires ability to make decisions independently and oversee important activitiesrelevant to clinical research activities according to predetermined global policies and

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

quality and project de

Proficiency in written and spoken English and local language. The incumbent must becompetent and effective in written and verbal communication.

Strategic thinking.

Ability to work efficiently in a remote and virtual environment

al diversity

The position requires proven strong project management skills and/or project managementor relevant training program/close mentoring.

Behavioural Competency Expectations:

Strong leadership skills that enable and drive alignment with the goals, purpose and

Ability to identify problems, conflicts and opportunities early and lead, analyse andprepare 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:

needs, 3) performance orcompliance issues, 4) working with regulatory issues and the broader organization, and5) resolution of conflictive situations.Educational/pedagogic, diplomatic and empathic skills to effectively build and maintainprofessional relationships with investigators and other stakeholders.

Experience Requirements:

5-6 years of experiencein clinical research

CRA Experience preferred

Educational Requirements:

Bachelor degreein Science (or comparable)

Advanced degree, (e.g., Master degree, MD, PhD)

Current Contingent Workers apply

Not ApplicableNot Indicated

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