Study Coordinator Supervisor
Overview
Lead study coordination and administration of ongoing studies ensuring accurate execution of SOPs and compliance with regulatory standards. Manage study initiation materials and coordinate with cross-functional teams to deliver effective client and vendor interactions.
What You'll Do48
- 1Perform periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs
- 2Maintain and submit study initiation materials
- 3Communicate effectively with all key stakeholders including vendors and clients
- 4Order all applicable supplies for studies
- 5Insure creation of data sheets and confirm lab math for test article and disease induction formulation
- 6Communicate with formulation department regarding timeline and materials needed
- 7Assist with in-life study conduct and maintain training documentation
- 8Ensure compliance with all policies and procedures including USDA AAALAC OLAW
- 9Perform quality checks, reviews, and formatting on all Inotiv documents
- 10Develop and maintain protocol report and data table master templates
- 11Provide backup support for Study Directors as needed
- 12Prepare and review raw data collection forms and verify adherence to protocol
- 13Assist in protocol amendment or deviation preparation and distribution
- 14Review raw data collection and in-life study conduct
- 15Help prepare complete study file for archival after report finalization
- 16Ensure proper shipping and documentation of study samples
- 17Train Study Coordinator personnel and relay updates to team members
- 18Serve as central point of contact for Study Coordinator issues
- 19Manage and distribute study workload among coordinators
- 20Verify study entries and schedules for accuracy
- 21Correct scheduling errors including oversight of handwritten activities
- 22Provide oversight during study scheduling
- 23Manage weekend and holiday staffing adjustments
- 24Maintain proper retention of scheduling documents according to SOP
- 25Standardize coordinator processes for consistency
- 26Contribute to process improvement and team operations
- 27Lead weekly coordinator meetings with regular coaching feedback
- 28Minimum Bachelor's degree in life sciences or related field with 5+ years in pharmaceutical setting
- 29Strong editing skills for protocols spreadsheets and reports
- 30Experience with Microsoft Office Pristima or Provantis
- 31Ability to work efficiently in individual and team settings
- 32Excellent written and verbal communication skills
- 33Attitude for quality and attention to detail
- 34Ability to interact and collaborate with scientific staff at all levels
- 35Able to work overtime as needed
- 36Extended computer and display screen equipment usage
- 37Physical requirement to lift 5 pounds unassisted
- 38Stand/walk for extended periods
- 39Critical Success Factor: Customer Focus
- 40Results Driven: Internal drive toward action to efficiently achieve results
- 41Efficient: Takes responsibility for own time
- 42Communication: Clear oral and written expression
- 43Collaboration: Supports team success and encourages cooperation
- 44Relationship Builder: Develops internal and external partnerships
- 45Critical Thinking: Identify key components of problems
- 46Problem Solving: Interpret information to spot patterns
- 47Organization: Plan and prioritize work effectively
- 48Time Management: Manage deadlines and priorities
Requirements34
- 1Bachelor's degree in life sciences or related field with 5+ years in pharmaceutical setting
- 2Prior management experience preferred
- 3Strong editing skills for protocols spreadsheets and reports
- 4Microsoft Office Pristima or Provantis experience a plus
- 5Ability to work efficiently in individual and team settings
- 6Excellent written and verbal communication skills
- 7Attitude for quality and attention to detail
- 8Interact and collaborate with scientific staff at all levels
- 9Work overtime as needed
- 10Extended computer screen usage
- 11Physical ability to lift 5 pounds unassisted
- 12Stand/walk for extended periods
- 13Compliance with USDA AAALAC OLAW regulations
- 14Quality checks and formatting expertise for Inotiv documents
- 15Protocol template development and maintenance
- 16Backup support for Study Directors
- 17Training documentation maintenance
- 18Proficiency in SOP management and revision
- 19Data sheet creation and verification
- 20Raw data collection form review
- 21Study sample shipping and documentation
- 22Process standardization for coordinator consistency
- 23Weekly meeting leadership with coaching feedback
- 24Retention of scheduling documents per SOP
- 25Coordination of study workload distribution
- 26Resource allocation based on department demands
- 27Verification of study entries and schedules
- 28Correction management for scheduling errors
- 29Study scheduling oversight
- 30Weekend and holiday staffing management
- 31Scheduling document retention policies
- 32Process improvement contributions
- 33Participation in weekly coordinator meetings
- 34Performance coaching for team members
Salary Insight
$72 - $89k per year
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