Our growing client, a specialty pharmaceutical firm that applies state-of-the-art biotechnologies to discover and deliver novel medicines in CNS/Parkinsons, movement disorders.
The Senior Clinical Trial Manager will be responsible for implementation and management of all aspects of clinical trial activities.
- Serves as the leader and coordinator for implementation of clinical trial activities and management of the clinical trial(s).
- Manages the CROs and service-specific vendors in the initiation, management, and completion of clinical studies according to ICH, GCP and company SOPs.
- Serves as liaison for select activities to support study programs as assigned.
- Leads or supports the study team’s identification and selection of CROs, service-specific vendors, KOLs and investigational sites.
- Manages the CRO’s deliverables in accordance with the study timelines.
- Manages and reports study milestones, status updates and alerts project team of potential delays.
- Initiates the team’s development and implementation of risk mitigation strategies.
- Provides clinical input into cross-functional activities.
- Manages the overall quality of the study data and TMF deliverables to collect, organize, manage and secure documents needed to allow the conduct of a clinical trial, the integrity of trial data, and the compliance of the trial with GCP to be evaluated.
- Provides clinical input and manages the study team’s development of the key study documents.
- Leads or supports in the completion of clinical sections for regulatory filings, e.g. NDA, DSUR.
- Support clinical and cross-functional teams with Health Authority inspections.
- Provides study specific training and education for internal and external project team members.
- Contributes to the ongoing scientific review of the clinical trial data during the course of the trial.
- Identifies and assists in streamlining and standardizing departmental policies/procedures.
- This position may require management of contractors and has no direct reports.
REQUIREMENTS
- Bachelor, Masters or Ph.D. degree
- 5 years+ pharmaceutical experience in clinical trials (CNS, Parkinsons).
- Must have a thorough understanding of clinical study design, CRF design, and project management and familiarity with data handling.
- Must have experience in supervising and managing vendors, especially CROs.
- Strong computer skills are essential, with a good working knowledge of Microsoft Office.
- This individual should possess a thorough understanding of clinical drug development and GCP and familiarity with regulatory requirements for conduct of clinical trials.
- Strong oral and written communication skills needed. Ability to multi-task essential.
- This position will require 25-30% travel.