Clinical Study Specialist
- India
- Permanent
- Full-time
- Organizes and delivers analyzable reports and metrics to the clinical study lead
- Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings
- Collates data for assessments such as feasibility and site selection and reviews site usability database
- Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures
- Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders
- Collates materials for training and investigator meetings
- Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan
- Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings
- Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance
- Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)
- Manages and maintains team SharePoint and/or shared drive sites, as needed
- Communication with sites as directed and maintains site contact information
- Contributes to line listings review for Blind Data Review Meeting (BDRM)
- May manage or contribute to oversight of Third Party Vendors (TPV)
- Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits
- Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives
- Proactively recommends process improvement initiatives for the department
- Must have a Bachelor's Degree
- Must have a minimum of 2 years industry related work experience
- Experience supporting global trials (NA, LAM, EU, APAC, India)
- Experience working in TMF, CTMS, Sharepoint,
- Excels in written and verbal communications
- Self-starter, can work independently with minimal oversight, solution-oriented
- ICF review experience
- General competency: powerpoint/excel skills, meeting minutes
- Vendor management/oversight experience a plus
- EST time preferred
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others