Clinical Study Manager - HIV
Proclinical is currently recruiting for a Clinical Study Manager of HIV with a pharmaceutical company located in Durham, NC. Successful candidate will support the responsible clinical scientists in the operational conduct of clinical studies by assisting with all aspects of the maintenance of clinical studies.
- Support the responsible clinical scientists in the operational conduct of clinical studies by assisting with all aspects of the maintenance of clinical studies.
- Ensure uninterrupted supply of study medication, appropriate safety monitoring, data collection, reporting of regulatory agency required updates, participating in identifying and implementing solutions to combine clinical studies from various programs into rollover trial(s).
- Ensure effective management of the study plan including all activities, budget, and timelines and other related duties as assigned.
- Ensure effective communications with Staff in the regions/countries with regards to study conduct.
Skills and Requirements:
- Bachelor's Degree in Life Sciences. Prior experience with HIV experience is highly desirable.
- Minimum of 5 years of experience from a CRO or Pharma working in clinical research, or clinical operations roles in the conduct of multi-center, international, clinical studies. (Examples are Study Manager, Clinical Research Scientist, Study Operations Leader).
- Understanding of running clinical trials and clinical training and/or applicable clinical research experience. Knowledge of using clinical trial master file (TMF) systems (paper or electronic) and associated business processes Knowledge of Trial Master File industry accepted standards, such as the DIA's TMF Reference Model.
- Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records.
- Excellent interpersonal and communication skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders.
- Proven record of being customer driven, ability to learn processes quickly, a self starter, and able to work in independently as well as in matrix team environment.
- Analytical / logical, with superior organizational skills and attention to details, addresses assignments in a timely and efficient manner.
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 Sarah Beshara at (+1) 267-477-3355 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.