Manager, Underwriting Support Services
Converge Insurance
Clinical Trial Manager II
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- The Clinical Team Manager (CTM) leads the clinical team to ensure successful delivery of clinical studies in accordance with protocol, budget, standard operating procedures, policies and applicable regulations.
- Ensures optimal productivity and quality to drive sponsor satisfaction and strong financial performance.
- Proactively identifies, resolves/mitigates and escalates risks and/or issues.
- Manages and prioritizes the clinical deliverables (e.g. site recruitment, site selection, subject/patient recruitment/enrollment, data monitoring, etc.) to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations.
- Maintains thorough knowledge of contract details. Escalates out-of-scope task requests for review and approval prior to execution.
- 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
Requirements
- Bachelor’s degree in a health, life sciences or other relevant field of study
- 8 years’ relevant experience
- Advanced project management skills
- Excellent leadership and influencing skills
- High proficiency with Microsoft Office and company collaboration applications
