MSD Clinical Research Manager 

Malaysia, Selangor, Petaling Jaya 

294140066

Job Description

Clinical Research Manager

• Based in Malaysia, named one of the Best Companies to Work for in 2019 by HR Asia
• Join the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse eventreporting requirementsinternally and externally.

Responsibilities include, but are not limited to:

• Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team.
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance ofdeliverables/timelines/resultsto 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 collaborateswith 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 Point of Contact 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, EUClinical Development,Pharmacovigilance, Global Medical Affairs to align on keyissues/decisions acrossthe trials. Consult with business as needed.

WHAT YOU MUST HAVE

• Min Bachelor degree in Science (or comparable)
• Advanced degree, (e.g., Master degree, MD, PhD) advantage

• 5-6 years of experience in clinical research• CRA Experience preferred

• Knowledge in Project Management and site management.
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee importantactivities relevantto 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 protocolssimultaneously.
• 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, qualityand project delivery.
• Proficiency in written and spoken English and local language.
• Strategic thinking.
• Ability to work efficiently in a remote and virtual environment.
• Understand cultural diversity.

What we look for…

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.