Senior Director - Clinical Operations - REMOTE (East Coast) job in Atlanta, USA

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Program Manager / Director, Clinical Scientist, VP/Head of Clinical Operations

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote Senior Director - Clinical Operations for a leading biotech company. This individual will be responsible for leading the planning and strategic set-up of a Clinical Trial Portfolio, including planning of required resources as well as relevant vendors and systems.

Must be eligible to work or be a citizen in the US.

Job Responsibility:

Oversee activities related to the heading of the project teams, the supervision/ control of third-party providers, the timely performance of all services, as well as stakeholder management of all departments involved
Oversee the development and review of portfolio documents such like Oversight Plans, Process Developments (including Trial RACI) and SOP development
Point of escalation in case of challenges in platform or vendor-related activities with other departments or external vendors; contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors
Taking care of team developments, identification of high-performance team members and working on team development
(Assurance of) Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)

Skills and Requirements:

Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Pharmaceutical Technical Assistant), combined with many years of experience in project management, regulatory submissions, and global study organizations
CAR T cell experience is preferred
Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects
Profound experience with the preparation and processing of national and international projects under consideration of the local laws, international guidelines (ICH GCP) and applicable SOPs
Excellent communication and ability to recognize problems and provide solutions
Able to rapidly enter in action and to work under stressful conditions
Able to motivate and lead a team

If you are having difficulty in applying or if you have any questions, please contact Ciara Noble at (+1) 323-518-2700 or c.noble@proclinical.com.

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.

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