ãMedicalã CMO Office, Clinical Trial Manager (Senior Staff)
ãMedicalã CMO Office, Clinical Trial Manager (Senior Staff)
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Job Description
Thisposition is responsible for the successful execution of local regional and/orglobal trials (clinical trials company initiated studies (CIS) Post MarketingSurveillance (PMS) and so on) for assigned projects/studies; this includesundertaking adequate planning obtaining deliverables within agreed timelinesand budgets ensuring high quality and meeting all of the companys StandardOperating Procedures (SOP) and regulatory requirements. This position leads theclinical team members (Product manager Regulatory Affairs lead ClinicalOperation team including CRO). The position is also responsible for thealignment of goals with organizational objectives.
1) Ensure trials (clinical trials CISPMS and so on) to be conducted in compliance with GCP/ GPSP/ SOPs localregulatory regulations procedures and protocols as Clinical Trial Manager(CTM)
2) Ensure any adverse events known fromtrials to be reported properly
3) Develop and ensures accurate budgetmanagement for assigned trials. This includes ensuring that vendors andaffiliate budgets are tracking according to plan. Updates are made to accountfor changes in the scope of the trial. Ensure project execution according totimeline and budget
4) Plan for study budgets and collaboratewith Clinical Lead to manage the development of Investigator agreements andsite contacts within fair market value payments and financial disclosures asneeded.
5) Drive the preparation ofrecruitment/contingency plans and implement ad campaigns as required. Ensuresthat enrollment commitments meet projected enrollments at the clinical triallevel monitors patient recruitment and ensures timely and accuratedocumentation communicating study progress and issue escalation.
6) Create and update study-specificdocuments such as Project Operation Manual Monitoring Plans Informed ConsentForm device related documentation and site feasibility related documents bycollaboration with Clinical Lead.
7) Ensures compliance with global/Localhealth authority regulations and guidelines and internal operating proceduresand processes. Participates in preparing for and conducting. Ensures that theClinical team operates in a constant state of inspection-readiness. Works withQuality Management liaisons to ensure quality oversight of assigned trialsusing all available tools.
8) In coordination with Clinical LeadClinical Operation Associates Study Medical Lead and/or members of the Globalteam CTM is responsible for providing appropriate trial-specific training tothe internal/outsourced trial team members and the site study staff. He or sheworks to set up and coordinate Investigator Meetings where applicable.
9) Ensures that deliverables are providedaccording to the trial plan. Provides updates to all internal/outsourced trialteam member on the status of deliverables. Ensures that all required reportsare generated and made available for real time tracking of the trial status inaccordance with the trial plan.
10) Develop and maintain workingrelationships with others requiring interaction and mutual support
11) Select and oversight External ServiceProviders (ESPs) included the Contract Research Organization (CRO) bycollaboration with Clinical Lead.
Required Experience:
Chief
Employment Type
Full-Time
