Our client is seeking a Senior Director of Clinical Operations in Boston, MA !
The Senior Director of Clinical Operations gives direction with the guidance of the CMO, in the lay-out, launch and completion of the global clinical trials to provide backing for both product endorsement as well as market acceptance of the products. The Senior Director of Clinical Operations will manage a group of executives as well as outside re-sellers to certify project deadlines are satisfied. The SDCO will head a team which will carry out project design, controlling estimated expenses, agendas and merchants at the same time following Standard Operating Procedures, governing and Good Clinical Practice requirements.
- Establish/Introduce a clinical model, “best practices” and methods to enhance every procedural area in conformity with universal requirements as well as building relationships alongside important useful spaces, outside contributors, project risk assessment; picking the research organization; overseeing location inauguration; experiment enrollment approaches; planning the project to ensure a streamline process between the company and the research organization; following and observing the development versus implemented methods
- Assemble, manage and serve as an example to back the proportion and outlook of the expanding program(s).
- Assist the manufacturer in establishing an analysis approach and plan of action, along with timetable estimates, determine program workability, budgeting, and improving the methods of operation.
- Form alliances with key opinion leaders, support groups and associates
- Give direction throughout the entirety of the trials
- Implement a process for medical editing/writing are established for GCP forms. Create study guidelines, IND document submission and communicating with health jurisdiction figures.
- Select/Manage the contract research organization: RFPs and daily clinical tasks for the outside research organization.
- Give regular trial status reports to people of interest.
- Setup a payment and tracking system for vendors.
- Create probability/risk assessment strategies for studies and assist the contract manufacturing organization with the same process.
- Work the QA department to make sure the companies’ standard operating procedures are compliant
- BA in life sciences or a similar area required (MS or Phd is preferred)
- Ten plus years in clinical research / Seven plus years in study management over every phase of a clinical trial.
- Expert in compliance rules and regulations as well as GCP/ICH requirements
- Managing multiple studies and understanding the clinical devices associated with each of the projects.
- Leadership overseeing an outside organization hired for research and vendors
- Managing tasks, team-building skills and the ability to resolve conflicts is a must
- Expect to travel 30% of the time
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