Coordinates the study contract and budget process with sites, investigators, and required Sirtex personnel
Creates and manages the internal study plans and timelines
Provide study-specific training and leadership to clinical research staff, Clinical Research Organization (CRO), Clinical Research Associates (CRA), sites and other contract personnel
May conduct initiation meetings, site selection visits, routine monitoring visits, and close-out visits, as well as assist in the organization of investigator's meetings and vendor kick-off meetings as appropriate
Track study progress and ensure data integrity including providing status updates to the clinical team and clinical senior management
Ensure all monitoring visit reports are completed in a timely manner
Ensure all study documentation and contracts are complete and filed
Assess clinical trial vendors and support with vendor selection and contracting
Oversee the operations and support financial budgets of clinical trial vendors
Track payments to clinical study sites and vendors in their region of responsibility.
Act as liaison between internal departments, investigational sites, and vendors
Ensure the completion of routine administrative duties such as arranging meetings and/or conferences, recording minutes, document copying and distribution and maintaining study files
Ensure regulatory compliance of investigational sites with company Standard Operation Procedures (SOPs), Quality Work Instructions (QWIs), national and international regulations including EU Directives, ISO 14155. Compliance to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with the Study Management Team (SMT) and Health Economics to design clinical study protocols consistent with the clinical development initiatives to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met
Prepare study-related documentation as necessary
Provide input for the design of the Informed Consent Form (ICF), Case Report Forms (CRF), monitoring conventions, and edit checks, etc
Develop relationships with investigators and site staff; select sites and countries (with Commercial input for pre- and post-marketing studies)
Collaborate with the regional clinical team to develop and manage study budget and maintain budget within financial goal, when assigned
Review clinical invoices against site contract and forward to Global Director of Clinical Operations for approval
Ensure all clinical studies are executed in compliance with international ICH GCP guidelines/regulations, QWIs and ISO 14155 where appropriate
Participates in the planning of quality assurance activities including preparation for audits and coordinating the resolution process to end point resolution of audit report observations and findings, including the coordination of the study documentation and central file reviews
Review monitoring reports in a specified timeline manner to ensure quality and resolution of site-related issues
Coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate
Coach, mentor and provide guidance to the CTA and other junior Clinical Operations staff

Requirements

Bachelor’s degree required or Master’s preferred
Minimum of 6-8 years of clinical study experience with on-site management responsibility
Experience leading IDE studies is required
At least 4 years of monitoring experience in pharmaceutical, medical device, bio- technology or CRO companies required
Understanding of ISO 14155 and fully conversant with ICH GCP guidelines, EU Directives and regulatory requirements
Strong clinical study management skills including management of vendors at site level
Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team building skills.

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical study managementmonitoring experiencevendor managementstudy protocol designbudget managementdata integrity trackingregulatory complianceaudit preparationclinical documentationinformed consent form design

Soft Skills

communicationorganizational skillsproblem solvingconflict resolutionleadershipteam buildingcoachingmentoring

Certifications

Bachelor’s degreeMaster’s degreeGood Clinical Practice (GCP)ISO 14155