For immediate consideration contact:
Lynda Merjil
Sr. Technical Recruiter
Lynda@alphaprotemps.com

The Clinical Trials Operations Manager is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including data management activities in compliance with GCP’s, SOPs and standards within established timelines and budgets.
The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other CSO department representatives (e.g. Medical Operations)
May be required to take-on the Dedicated Project Expert (DPE) role depending on CTOM’s level of experience, relevant skill-set and business needs.

1. Provide oversight of a study to ensure progress according to study timelines.
2. Ensure proper documentation/availability
3. Ensure proper collection and validation of data and documentation on a timely manner
4. Coordinate and support field-monitoring activities through regular meetings: teleconferences. Prepare and lead data review meeting, organize and contribute to medical review meetings.
5. Maintain and provide information for monthly study highlights (including enrollment curves and timelines) on a timely manner.
6. Investigational Product (IP) Management.
7. Participate in the development/follow-up of the study budget and selection and management of vendors.
8. Preparation and oversight of study audits/inspections both internal and external
9. Provide oversight and preparation for FDA pre-approval inspections (PAI)


Submit resume to: Lynda@AlphaProTemps.com