Clinical Operations Specialist
1 week ago
Bicycle Therapeutics is a clinical-stage pharmaceutical company pioneering a novel class of medicines referred to as Bicycle molecules. These molecules are fully synthetic short peptides constrained with small molecule scaffolds, making them attractive candidates for drug development.
The company is evaluating zelenectide pevedotin, BT5528, and BT7480 in company-sponsored clinical trials. Additionally, Bicycle Therapeutics is developing Bicycle Radio Conjugates (BRCTM) for radiopharmaceutical use and exploring the use of Bicycle technology to develop therapies beyond oncology.
Job DescriptionWe are seeking a highly skilled Clinical Operations Specialist to support our growing TMF Operations Department. The successful candidate will have experience in electronic trial master file eTMF systems, advanced understanding of eTMF system functionality, document workflows, and navigation.
This role involves working with internal and external study teams to ensure that Bicycle eTMFs are complete and comply with regulatory standards and governing SOPs. Key responsibilities include contributing to process improvement initiatives for clinical document management and clinical trial records, reviewing and updating study specific TMF Plans and Indexes, and supporting the development of TMF metrics and KPIs related to inspection readiness.
- Contribute to process improvement initiatives for clinical document management and clinical trial records.
- Review and update study specific TMF Plans and Indexes based on feedback received from leads.
- Support the development of TMF metrics and KPIs related to inspection readiness.
To be successful in this role, you should possess:
- Experience with electronic trial master file eTMF systems and advanced understanding of eTMF system functionality, document workflows, and navigation.
- Prior experience in a clinical operations role or in clinical quality assurance.
- Solid understanding of the clinical trial process.
- In-depth knowledge of TMF Reference Model (CDISC).
- Knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process.
Bicycle Therapeutics offers a competitive salary package including:
- An estimated annual salary of $80,000-$120,000 depending on experience.
- Flexible working environment.
- Competitive benefits including medical, dental, and vision insurance, 401(k) plan, and paid time off days.
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