Clinical Team Manager

5 days ago

Singapore PHARMACEUTICAL RESEARCH ASSOCIATES SINGAPORE PTE. LTD. Full time

ICON is currently looking to hire a Clinical Team Manager to join our business.

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Primary Responsibilities
- Creates and administers clinical and site training plans. Ensures clinical team understands responsibilities and performance standards. Reviews metrics and other information sources to monitor team and individual performance. Provides timely feedback to address performance issues; shares performance information with functional manager as appropriate. Collaborates with a cross functional group of site monitors, site managers, biometrics team members to achieve successful delivery of data. Ensuring timely data entry, query resolution, on and off site data review, to ensure on time quality data deliverables.
- Maintains detailed knowledge of study resource requirements, burn rates and plans accordingly, ensures timelines, quality standards and budget expectations are met. Forecasts according to contractually agreed units/hours, tailoring to manage fluctuation of activities throughout project duration.
- Recognizes potential risks within the study protocol and operational aspects of the trial; serves as the primary liaison for clinical monitoring, site risks and issues; proactively establishes contingency and mitigation plans. Analyzes metrics and reports to keep abreast of performance. Leverages plans to address issues.
- Ensures that quality standards and applicable regulatory requirements are met. Collaborates with quality assurance department members to identify study sites requiring corrective and preventative action plans. Facilitates internal audits and local health authority inspections as needed.
- Oversees filing of study and site level essential documents by project team members to ensure that all initial or amended study information is submitted, approved and filed in accordance with the protocol, applicable guidelines and local regulations.
- Communicates effectively with sponsor, project manager, functional team leads and other project team members. Selects appropriate communication platforms to convey information effectively and efficiently. Leads clinical study team meetings; presents at intra-/inter-departmental and external meetings.
- Creates, maintains and collaborates on applicable project documents, plans, templates and tools.

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