Your Browser is Not Supported

To ensure jobstore run smoothly, please use the latest version of the following supported browsers:

Jobs in Malaysia   »   Jobs in Malaysia - Singapore   »   Business Management / Project / Planning jobs   »   Sr Project Manager

Sr Project Manager

Malaysia
JOB SUMMARY

The position provides customer focused leadership in managing and delivering the operational

and financial aspects of one or more clinical projects from proposal development to final

deliverables and ranging in size and complexity from single service studies to full scope,

multiple protocol projects and/or global projects across various phases and functional areas with

limited interaction from supervisor. May oversee less experienced Project Managers (PMs) and

have line management responsibilities.

JOB RESPONSIBILITIES

Project Leadership and Delivery:

 Manages a project as Project Manager overseeing interdisciplinary clinical research

programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard

Operating Procedures (SOPs) and regulatory requirements.

 Acts as primary liaison between the Company and the Customer to ensure project

launch, conduct, and closeout according to the Customer’s and the Company's

contractual agreement.

 Leads clinical team to ensure quality, timelines and budget management.

 Accountable for the financial performance of assigned projects

 Accountable for all project deliverables for assigned projects and/or project regions.

 Coordinates activities and deliverables of all project conduct partners and proactively

identifies and manages issues.

Reporting and Communication:

 Accountable for maintenance of project information on a variety of databases and

systems.

 Maintains and evaluates project progress by maintaining timelines and other

tracking/analysis tools.

 Responsible for project management components of inspection readiness for all aspects

of the project conduct, including Trial Master Files.

 Provides oversight for development and implementation of project plans in accordance

with Controlled Documents.

This document has been electronically approved. Refer to the Approval Certificate at the end of the document for details.

 Independently prepares, coordinates, and presents project material at internal and

external meetings.

 Directs the activities of assigned Project Support staff; line manages and mentors other

project management team members and clinical staff; facilitates team building and

communication.

 Prepares project management reports for clients and management.

 Implements resource strategies to achieve project goals.

 Develops contingency planning and risk mitigation strategies to ensure successful

delivery of project goals.

Business Development

 Participates in bid defense meetings where presented as potential project

manager/director.

 Develops strong relationships with current clients to generate new and/or add-on

business for the future.

 Keeps a current awareness of business unit’s and assigned projects’ therapeutic

environment and drug development trends

Management:

 May train and support new Project Managers. Facilitates team training in accordance

with protocol and/or project requirements, including therapeutic, protocol specific, and

process training.

 May be required to line manage other project management team members and clinical

monitoring staff

Qualifications

QUALIFICATION REQUIREMENTS

 Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine,

Pharmacy, Nursing or related field or equivalent combination of education and

experience.

 Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements,

drug development process and clinical monitoring procedures.

 Clinical research organization (CRO) and relevant therapeutic experience preferred.

 Strong ability to manage time and work independently.

 Ability to embrace new technologies.

 Excellent communication, presentation, interpersonal skills, both written and spoken

 Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to

meet deadlines delivering high quality work in a dynamic environment.

 Ability to travel as necessary (approximately 25%).

 Preferably eight years relevant clinical research experience with an

understanding of clinical drug development and clinical operations preferred; minimum of four years of project management experience preferred.
✱   This job post has expired   ✱

Sharing is Caring

Know others who would be interested in this job?