Description
The Clinical Trials Manager will work under the supervision and guidance of the Director, Clinical Operations to ensure completion of the following clinical drug development activities:Essential functional duties -
· Requires minimal supervision to manage various activities associated with multiple clinical studies in accordance with designated project assignments.
· Has had experience as clinical operations co-lead/lead on a significant Phase II or Phase III program.
· Independently designs study related documents including but not limited to: clinical protocols, case report forms, site study manuals and project tools, monitoring plans, tracking tools, informed consent forms.
· Support of departmental functions for preparation and/or attendance at departmental meetings, clinical operations training and developmental activities as required and directed.
· Manages study-specific CROs and vendors and contract CRAs as appropriate.
· Performs monitoring of sites as required by needs of project with minimal guidance or supervision.
Secondary Functions -
Adds insight regarding evaluation and selection of CRO's, contractors and other outside vendors.
Coordinates efforts in study start-up, including study feasibility, site selection, preparation and follow-up of site regulatory packages in coordination with other clinical operations staff and other departments as appropriate.
Works with Financial Operations Coordinator on vendor and study site budget tracking and compliance.
Skill Requirements -
BA/BS in science-related field with a minimum of 5 years work experience as a Sr. CRA or CTM or combination of relevant related work experience.
· Excellent written and verbal communication skills required.
· Demonstrated thorough understanding of FDA regulations and GCP.
· Well-developed and strong problem solving skills.
· Exceptional interpersonal skills with demonstrated successful team participation.
· Demonstrated skill in managing multiple tasks simultaneously, with attention to detail.
· Proficient in use of Microsoft applications such as Word, Excel, Power Point, etc.
To find out more about Real please visit www.realstaffing.com