Msd Malaysia | Clinical Research Project Manager | Ryde
vor 1 Monat
Clinical Research Project Manager Apply remote type Hybrid locations AUS - New South Wales - Macquarie Park time type Full time posted on Posted 17 Days Ago time left to apply End Date: December 11, 2024 (9 days left to apply) job requisition id R318645
Clinical Research Project Manager
Permanent Full-time position with competitive remuneration and benefits Location: Macquarie Park, Sydney, Australia Hybrid, work from office and home environment, with a dedicated and welcoming team Join a growing, yet already successful market Upskill and growth in an area you're passionate about , whilst being fully supported and encouraged Join a trusted Global leading Pharmaceutical organisation What You Will Do
Responsibilities include, however 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.
Identifies and shares best practices across clinical trials, countries, clusters.
Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
As a customer-facing role, this position will maintain and build business relationships representing our company to investigators, and site staff.
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.
CORE Competency Expectations:
Knowledge in Clinical Project Management and site management.
Strong organisational 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 Therapeutic Area Head or Clinical Research Director.
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 an office/virtual environment and across countries, cultures and functions.
Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.
The incumbent must be competent and effective in written and verbal communication.
Ability to work efficiently in an office and virtual environment.
The position requires proven strong clinical project management skills and/or formal project management certification or relevant training program/close mentoring.
What You Must Have
Required: Bachelor degree in Science (or comparable)
Preferred: Advanced degree, (e.g., Master degree, MD, PhD)
Solid prior experience in clinical research and clinical project management essential Experience working in Oncology therapeutic areas preferred CRA experience preferred What You Can Expect
Work autonomously whilst being supported, encouraged and being part of a trusted Global leading organisation Exposure to upskill and develop in your role Flexibility and opening doors to other opportunities and skillsets Joining a collaborative team of likeminded individuals We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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