Associate Director - Clinical Operations
Proclinical is currently recruiting for an Associate Director of Clinical Operations with a CRO located in Blue Bell, PA. Successful candidate will be responsible to review submitted IIS proposals and execute, track, manage and oversee approved IIS protocols.
- Manage IISs, working closely with the Therapy Area (TA) Lead, Medical Directors, Medical Science Liaison (MSL) team, and Global Development (GD).
- Manage all studies in partnership with the Study Responsible Physician and Research Scientists for US Medical Affairs sponsored studies to ensure that these company sponsored studies are conducted and executed in a timely manner.
- Participate in SOP review and department wide activities such as serving on cross functional initiatives to provide MAF Immunology voice.
- Lead cross functional teams for evaluating new product ideas, implementing franchise business strategies, and/or developing and monitoring strategies for clinical process effectiveness.
- Manage the interpretation of results, preparation of oral and written internal/external presentations; development, management and tracking of trial budgets and budget and contract development with third party vendors.
- Manage monthly/periodic meetings to monitor and update organizational logistics of IIS proposal intake, review and tracking.
- Manage and tracks adverse event data collection across trials (IIS and company sponsored).
- Contributes to protocol planning and development.
Skills and Requirements:
- BS degree required.
- 7 years within the pharmaceutical industry, min of 5 years in management or accountability for IIS research and/or full clinical trial phase IIB -IV.
- Strong leadership, interpersonal and communication skills required. The ability to operate in a matrix environment and be experienced with cross-functional alliances is required.
- Previous contract management/negotiation experience desired.
- Financial planning and tracking experience is desired.
- Ability to think creatively, critically and proactively with strong problem-solving skills. Collaborative and flexible in personal interactions at all levels of the organization.
- Willingness to jump in to help in areas that may not be familiar or consistent with their job description in order to achieve results.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Mary Jacobs at (+1) 312-291-4181 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.