Job Description

Working closely with our service providers, central laboratories and other specialized clinical trial vendors to support clinical sample and central imaging/ePRO reconciliation activities. Serve as the key point of contact for sample management for the clinical trial teams and cross functional departments. Work with the vendors, data management, and clinical operations group to reconcile central imaging, ePRO, and other electronic data capture services. Develop robust processes to facilitate the planning, coordination, and oversight of all logistical activities required to manage the lifecycle of clinical trial specimens.

• Support end-to-end global sample tracking and logistics for clinical samples (from sample collection until destruction).
• Provide query management support by working closely with the clinical trial vendors specialized laboratories, cross functional departments, and other relevant stakeholders
• Review central laboratory study documentation such as laboratory manuals
• Report trends with lab sample collections including sample inventories
• Attend routine meetings with the study team, the central laboratory, and the specialized laboratories
• Help to develop best practices for resolution of sample related data reconciliation and sample related activities by working collaboratively with relevant stakeholders
• Plan & oversee sample shipments to specialized laboratories for sample analysis to align with the bioanalytical and biomarker sample testing strategy
• Track and reconcile ePRO and central imaging records
• Other related duties as required

Qualifications

Essential:

• Able to create excel trackers for sample tracking
• Ability to work independently
• Knowledge of ICH-GCP guidelines
• Strong ability to identify, analyze, and communicate problems
• Basic understanding of study protocol and study activities
• Strong collaboration and communication skills

Desirable:

• Previous experience with sample management software
• 1+ years’ experience related to operational processes or systems in clinical trials

Additional Information

• Flexible working environment
• Competitive reward including annual company bonus
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company
• Health and Dependent Care Flexible Spending Accounts
• 401(k) plan with a 4% Company match and immediate vesting
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days
• Employee assistance program
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

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.