Clinical Trial Manager

Job type:
on-site
Start:
08/2014
Duration:
n.a
From:
Real Staffing
Place:
Berkeley
Date:
08/29/2014
Country:
flag_no USA
project ID:
767111

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Responsibilities:
  • Provides direction and leadership to one or more clinical operations teams
  • Develops operational plans including site monitoring strategies, trial budgets, site selection, and clinical supplies management.
  • Creates team culture and promotes team spirit.
  • Develops and maintains effective working relationships with all team members, with particular focus on internal teams, external CRO (for outsourced teams) and co-development partner study teams.
  • Oversees the development and maintenance of study specific manuals.
  • Contributes to the development and management of the study timelines, resources, and budgets
  • Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Senior Director, Clinical Operations.
  • Develops and manages clinical study budgets and contributes to staffing/resourcing plans. Communicates variances in the budget and action plan for resolution to the Senior Director.
  • Ensures accurate tracking and reporting of study metrics.
  • Provides operational input into the development of protocol feasibility questionnaires.
  • Provides clinical operations expertise to ensure operational feasibility and delivery
  • Participates in the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
  • Chairs operations subteam meetings as necessary.
  • Coordinates with Regulatory Affairs to prepare responses to study questions or issues from Health Authorities or IRBs/IECs.
  • Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
  • Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
  • Identifies areas of best practice and process improvements Assists the Senior Director and/or Quality group with SOPs and training requirements
  • Participates in Clinical Operations initiatives and programs as assigned.
  • Maintains oversight and ensures consistency of the operational aspects across studies within a project.
  • Ensures study adherence to ICH/GCP and SOPs


Job Requirements:
  • Proven clinical development experience of the operational aspects of all stages of clinical studies, preferably working in a global environment and/or including monitoring or leading clinical subteams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
  • Experience managing CRO's on large, global phase III clinical trials.
  • Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans.
  • Good knowledge of ICH GCP Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
  • Experience of working as part of a team and leading small study or functional subteams, with a proven ability to be an active member of the team and motivate and lead a small subteam to deliver against commitments.
  • Well-developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
  • Life sciences degree or nursing equivalent.
  • At least 4 years clinical operations experience at CRA or higher level.


Cardiology background desirable