Senior Clinical Operations Manager

Anocca


Anocca is a dynamic platform-based biotechnology company, based in modern labs in the Biovation Science Park in Södertälje. We are leading the way to a new generation of cancer therapies that harness the power of the immune system. We are a young group of more than 100 people from over 30 countries, and we are growing rapidly. At Anocca we have developed a proprietary, innovative biological platform for high-throughput, systematic interrogation of the human immune system with high precision, which is first aimed at enabling treatment of cancers. With a range of novel capabilities, Anocca is continuing to deploy our proprietary technologies into new areas of research, while also focusing on bringing our first T-cell therapies for cancer to clinical trials using our own manufacturing capabilities. We are now strengthening our internal clinical team.


Job Description


In this role, you will play a key role in leading the operation of our clinical trials. You will have specific responsibility for the strategic and operational relationship between Anocca and clinical CRO(s) who will operate the studies, and be a key senior member of the clinical team. Your duties will include:


- Being responsible for the management of day-to-day clinical operations activities

- Participate in CRO process including selection, request for proposal and management.

- Participate in bid defense presentations in partnership with the business development and other cross-functional departments.

- Oversight of CRO operations, including clinical trial site initiation, contracting, training, execution and monitoring.

- Oversight of delivery of study results, completion of clinical study reports and trial master files

- Engage in SOP development.

- Contribute to strategic development of clinical operations

- Contribute to regulatory submission.

- Accountability for operational clinical trial budget.


Required skills:


- Master's degree  or higher in a scientific or healthcare-related field (e.g., Life Sciences, Biotechnology, Nursing, Pharmacy).

- Significant experience in clinical operations within the biotechnology, pharmaceutical, or CRO industry, preferably in the ATMP field and/or in early phase oncology.

- Strong knowledge of clinical trial management, including study start-up, monitoring, data management, and regulatory compliance.

- Thorough understanding of GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA) governing clinical trials.

- Proven experience in managing multiple clinical trials simultaneously, from initiation to completion.

- Excellent organizational skills, with the ability to prioritise tasks, manage timelines, and work effectively in a fast-paced environment.

- Strong leadership abilities, with the capacity to motivate the clinical teams and guide cross-functional teams and operational CRO partners to achieve study objectives.

- Exceptional communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

- Proficient in utilizing clinical trial management systems (CTMS) and electronic data capture (EDC) platforms.

- Detail-oriented mindset with a strong focus on quality and compliance.