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Copy of Senior Study Start Up Associate

4 months ago

Linton, United Kingdom Bicycle Therapeutics Full time
Job Description

We are looking for a Study Start Up Associate that will be responsible for supporting the successful execution of global start-up, maintenance, and close-out.

The position will be a member of the Clinical Operations group, reporting to the Associate Director, Clinical Operations.

  • Responsible for performing country and site feasibility, site identification, site contract negotiation, and other study start up (SSU) activities independently or in partnership with internal stakeholders and external CRO partner.
  • Contribute to study vendor selection and onboarding
  • Support negotiation and execution of Investigator/ Institution contracts
  • Contribute to project meetings including internal meetings and CRO/ vendor meetings
  • Develop, review, and finalize study start up materials including Master and Country Specific Informed Consent Forms and participant materials.
  • Responsible for the quality oversight of the preparation and coordination of initial and ongoing submissions to IRBs/ECs including timely follow up for IRB/EC queries.
  • Responsible for the collection and maintenance of the current IRB/EC submission information
  • Support the coordination and preparation of submissions to Regulatory Agencies (RA) and/or Competent Authorities (CA)
  • Responsible for the collection and maintenance of the current RA/CA submission information.
  • Assist with the timely follow-up to questions raised by RA/CA.
  • Responsible for the timely and accurate tracking of all global SSU activities and providing updates on start up status, KPIs and metrics to internal stakeholders and leadership
  • Responsible for TMF inspection readiness for SSU documents
  • Participate in the development of WIs and SOPs associated with study startup activities

Qualifications

Essential:  

  • Bachelor’s degree in scientific, biological, life sciences, or related field
  • Familiarity with ICG, GCP, and FDA requirements, as applicable, for clinical trial management
  • Strong organizational skills and enjoys working in a methodical way
  • Strong analytical and problem-solving skills
  • Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment
  • Attention to detail and quality
  • Excellent written and oral communication skills
  • Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
  • Flexible approach to change

Desirable:  

  • Early phase and/or Oncology experience


Additional Information

  • State-of-the-art campus environment with on campus restaurant and Montessori nursery
  • Flexible working environment
  • Competitive reward including annual company bonus 
  • Employee recognition schemes
  • 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually
  • Employer contribution to pension (employee does not have to contribute) 
  • Life assurance cover 4x basic salary 
  • Private Medical Insurance, including optical and dental cover 
  • Enhanced parental leave policies
  • Group income protection
  • Employee assistance program
  • Health Cash Plan
  • Access to company subsidized gym membership
  • Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc. 
  • Cycle to work scheme  

All your information will be kept confidential according to EEO guidelines.

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.