Clinical Project Manager Job In Dublin

Job Description

Title:
Clinical Project Manager(CPM)

Reports to:
Chief Operations Officer (COO) Key Requirements Science and/or medical or nursing background.

Minimum5years Clinical Researchexperience,oncologyanadvantage.

Provenabilitytodeliverprojectgoalsandmentorjuniorlevelemployees.

In-depthknowledgeofthe Irishclinicaltrialsenvironment.

Experiencewithdraftingandmanaging Clinical Trialbudgetsanadvantage.

Excellent communication skills with the ability to represent the company at an international level.

Main Function(s) Maintain knowledge and ensure conduct of assigned studies is in compliance with ICH-GCP, regulatory requirements, applicable guidelines, Standard Operating Procedures (SOPs), study protocols and project-specific procedures.

Manage successful execution of multiple projects and lead cross-functional project teams.

Primary Responsibilities Manage assigned studies from concept to final study report in line with ICH-GCP, regulatory requirements, applicable guidelines, Standard Operating Procedures (SOPs), study protocols and project-specific procedures.

Developandmaintainstrongrelationshipswithexternalstakeholderstoidentifynewstudies and manage ongoing collaborations.

Contributetotheoversightandexecutionofkeyoperationalstrategiesandprocesses.

Leadprotocoldevelopmentforassignedstudiesandliaisewiththe Cancer Trials Ireland Study Start-up team as required.

Developandexecutestudyplansincludingsettingprojectgoals,leadingriskassessmentand management, planning resources and timelines, and study team oversight.

Manageroleandproject-specifictraining.

Overallresponsibilityformanagementofessentialdocumentsand Trial Master Filerelatedto assigned studies.

Overseetheprocessofsitevisitsanddocumentationofthevisits.

Pre-emptivelyidentifypotentialissuesandproactivelymanageresolutionsandputinplace, where possible, measures to minimise issues and risk for assigned studies.

Contribute to preparation for audits and inspections, conduct, and follow-up as required both internally and at investigational sites for assigned studies.

Assistasrequiredwithdraftingandfinalisingbudgetsandrolesandresponsibilitiespriorto commencing study activities and manage throughout the lifecycle of the study.

Takeallreasonableprecautionstoensurepatientconfidentialityismaintained.

Contributetodepartmentalandcross-functional SOPdevelopmentandupdatesasrequired.

Update COOonthestatusofallclinicaltrialactivities.

Identifyandcommunicatescientificmisconductaccordingto Cancer Trials Irelandpolicies.

Perform other tasks as specified by COO.