Head of Clinical Operations

Vor 3 Tagen

Basel, Schweiz Proclinical Vollzeit

Proclinical are recruiting for an experienced and highly motivated Head of Clinical Operations to join our biotech partner specialised in detecting and treating cancer through breakthrough novel radiotherapeutics.

Report into: Chief Medical Officer

**Responsibilities**:

- Lead the clinical operations team and ensure that projects are successfully executed.
- Develop and implement strategies to ensure the team is well organised and efficient.
- Monitor and evaluate team performance and identify areas for improvement.
- Collaborate with project teams to develop and execute clinical trials.
- Oversee clinical study execution (set up to close out) to ensure studies are completed on time, within budget, and in compliance with current SOPs, regulations and ICH/GCP guidelines.
- Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocol. Identify any gaps in company/CRO SOPs and develop internal SOPs as needed.
- Manage and develop relationships with external stakeholders risks are managed proactively.
- Directly involved in leading site set up activities including field visits working with partner CRO/s.
- Establish and maintain quality standards for clinical operations.
- Develop and evaluate clinical protocols and research plans.
- Collect and analyze data from clinical trials.
- Develop presentations to report progress and results.
- Ensure regulatory compliance and ethical standards for clinical operations.
- Identify, qualify, manage, and maintain relations with clinical trial sites such that site-based.

**Qualifications**:

- Bachelor's degree in a related field, such as biology, biophysics, or bioengineering.
- 10+ years of experience in clinical operations, preferably in a biotech setting.
- Established experience in building and leading an experienced Clinical Operations / Study team.
- Excellent communication, organisational, and problem-solving skills.
- Knowledge of clinical trial regulations and ethical standards.
- Proficiency in Microsoft Office and project management software.
- Ability to work independently and as part of a team.
- Detail-oriented and able to handle multiple tasks simultaneously.
- Strong leadership and interpersonal skills.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-RN1

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