Study Start Up Associate

Company Description
Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.
**Culture** is key and all Bicycle employees actively embrace and role model our company values:

- We are **Adventurous**. We believe it’s the way to deliver extraordinary results for our patients.
- We are **Dedicated to our Mission**. You can’t change the world if you don’t have determination.
- We are **One Team**. We only succeed when we work together.

**Job Description**:
We are looking for a Study Start Up Associate that will be responsible for assisting the Clinical Operations team in the development of the plan for country and site distribution and execution of Study Start Up (SSU) activities. The position will be a key member of the Clinical Operations group, reporting to the Associate Director, Clinical Trials.
**KEY RESPONSIBILITIES**:

- Responsible for performing feasibility, site identification, site contract negotiation, and other study start up activities independently or in conjunction with a CRO partner.
- Assist in selection of and onboarding of Study specific Vendors
- Support in negotiation and execution of Investigator/ Institution contracts
- Provide country specific study start up expertise to study team leads and project teams.
- Develop, finalize, and review Master and Country Specific Subject Information Sheets/Informed Consent Forms.
- Responsible for the oversight of preparation and coordination of submissions to ethics, and other bodies.
- May be responsible for the coordination and preparation of submissions to Regulatory Agencies (RA) and/or Competent Authorities (CA)
- Responsible for the collection and maintenance of the current Ethics Committee (EC) submission information, and similar information for other related submissions.
- May be responsible for the collection and maintenance of the current RA/CA submission information.
- Perform independent quality review of submission packages.
- Responsible for coordinating the timely follow-up for questions made by EC.
- May be responsible for coordinating the timely follow-up to questions raised by RA/CA.
- Responsible for the timely and accurate tracking of all relevant study start up activities in all countries.
- Comply with all department requirements regarding information provision and status updating and reporting.
- Responsible for TMF inspection readiness for study start up documents, collaborating with cross-functional colleagues where appropriate.
- Responsible for coordinating WI and SOPs associated with study startup activities.
- Responsible for coordinating the required clinical trial public disclosure activities.

**Qualifications**:

- Bachelor’s degree in scientific, biological, life sciences, or related field
- Demonstrable experience in supporting study start up activities of clinical studies at a CRO or biopharmaceutical company
- Familiarity with ICH, 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
- Excellent written and oral communication skills
- Proficiency with Microsoft Office (Excel, Word, Outlook, PowerPoint, SharePoint)
- Flexible approach to change

Additional Information
- State-of-the-art campus environment
- Competitive reward including annual company bonus
- 28 days annual leave in addition to bank holidays
- Employer contribution to pension (employee does not have to contribute)
- Life assurance cover 4x basic salary
- Private Medical Insurance, including optical and dental cover
- Health Cash Plan
- Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
- Cycle to work scheme
- 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._