Clinical Project Manager

Core Responsibilities

• Manage the performance of all aspects of project delivery from commencement to completion, under the supervision of the Project Director and PM line manager, including:

o Coordinate the activities of internal and external stakeholders including the Sponsor, third party

vendors and site staff to execute projects within agreed timelines.

o Maintain effective Sponsor communication to proactively manage project timelines, expectations,

risks, and issues.

o Prepare or review Ethics Committee submission documents, as required.

o Develop all study plans and documents to support the effective execution of all Project and

Clinical Operations activities.

o Identify, evaluate, control, communicate, review and report risks in relation to a project and its

critical processes/data.

o Ensure protocol deviations are identified, documented, and reviewed in line with study plans.

o Review and Quality Control (QC) check Trial Master File (TMF) documentation to ensure accurate

and timely filing as per SOP requirements.

o For a single-site study, oversee and lead the operations of the clinical team, develop the Clinical

Monitoring Plan and review Monitoring Visit Reports.

o Effectively manage project financial performance of assigned projects, including revenue

recognition, forecasting and contract management, sponsor invoicing, site payment management

and tracking, vendor payment management and tracking.

o Review and/or oversee site budget and clinical trial agreements development.

o Review study protocols and other study related documents.

• Participate in study-specific or vendor audits conducted by sponsors or regulatory agencies, and

respond to audit observations, as required.

• Ensure Serious Adverse Events are reported (initial and follow-up) as per protocol requirements.

• Other duties as directed by Line Management or delegate in line with skills, experience and/or

qualifications.

Departmental Responsibilities

• Foster the on-going commitment to maintaining a healthy team culture and promoting good morale, by

actively participating in regular Project Management Team meetings.

• Maintain effective communication with other members of the department.

• Proactively identify risks related to departmental service provision and assist in their mitigation and

resolution.

• Manage and track business related expenses as per company policy.

• Participate in internal Quality Assurance activities as required, including responding to audit findings.

Organisational Responsibilities

• Embrace the core values of Avance Clinical and endeavor to display those attributes at all times with clients and staff alike.

• Commit to Avance Clinical training programs.

• Adhere to Avance quality systems.

If you're passionate about the role, let's connect via below contact information, thanks!

E: [Confidential Information]

D: +886 930 700 872