Associate Director, Clinical Operations

vor 2 Wochen

Munich, Deutschland Proclinical Vollzeit

Proclinical are recruiting an Associate Director, Clinical Operations - Infectious Diseases for a biotech organisation. This role is on a permanent basis and is located in Germany. The client is focused on translating science.

**Responsibilities**:

- Accountable for guaranteeing study timelines are per plan or mitigations are introduced to limit timeline shifts.
- Guiding the cross functional clinical team for clinical study implementation on the program level and the study implementation actions for one or more studies.
- Collaborate with the cross functional team and the CRO to plan and gather documents for regulatory and ethics proposal, along with replies to any queries.
- You will plan, evaluate, and perform training sessions pertinent to studies, as well as team and investigator meetings/PSVs/SIVs, etc.
- Allocate and monitor one or more clinical trial managers/clinical trial specialists designated to the studies within the program.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to a degree level in a life science or similar discipline with work experience in a health organisation.
- A PMP or equivalent certification would be ideal.
- Expertise and familiarity with global regulations such as (ICH-GCP/CFR) for the performance of clinical research projects.
- Familiarity with acknowledging regulatory inspections or internal process audits.
- At least 8 years of experience in a pharmaceutical/biotech or similar organisation with at least 6 years of experience in international clinical development leading cross-functional teams.
- Acquaintance with vaccine/infectious illnesses would be beneficial.
- Communication and presentation skills both verbally and in writing.
- Project management abilities which involve teamwork, analytical and problem-solving, time management and organisational skills, risk and cost management, and performance monitoring.
- Computer literacy.
- Prior involvement in vendor oversight and management.
- Works well independently.

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-JH3

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