Snr Clinical Trial Manager : Rare diseases, Hemophilia

Massachusetts  ‐ Onsite
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Description

A position has become available that may interest someone in your network:

A growing Biopharma specialising in Rare diseases, Oncology and Hemophilia are looking to expand their Clinical Operations team.
The seek a Senior Clinical Operations Manager to work on their new early phase clinical trials

Location: Cambridge Massachusetts

Responsible for all aspects of clinical study planning and execution within pre-specified program plan, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors; in particular CRO(s), supervision of study related activities, identification of project risks and contingency planning.
Manage integrations of all project team activities; leveraging internal resources, expertise and knowledge.
Execution of clinical trials from protocol design to the final clinical study report for specified studies.
Manage all aspects of CRO identification, request for proposal submission, CRO selection, and the day to day study management activities of CROs, with the ability to leverage resources, expertise, and knowledge within the CRO.
Manage study sites and tracking systems for regulatory documents, CRO monitor visit reports and site correspondence, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc.
CRF and ICF review.
Coordinate all efforts for the trial both within the company and through a wide variety of CROs and vendors.
Participate in discussion and help develop contingency/risk management plans for projects and assist Director/Senior Director of Clinical Operations in the preparation and execution of sound development strategies.
Budgets, timelines, and forecasts preparation for clinical studies.
Create, track, and manage project budgets and timelines with an ability to provide comparison updates of financial accruals versus projected budgets.
Interface with Finance, Program Management, and Accounting which may include acting as a liaison between Clinical and Finance.
Review and approve and code vendor invoices for payment. Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
Ability to travel (no more than annual average of 20%).

Qualifications:
Bachelor's Degree is required. An advanced degree in scientific discipline, business/finance courses is preferred.
3+ years of experience gained with a CRO or Pharmaceutical Company working on Phase I - IV multinational clinical studies.
3+ years clinical project management experience with clinical studies.
Strong regulatory knowledge, including Good Clinical Practices (GCPs).
Extremely strong organizational skills and ability to deal with competing priorities, also strong reasoning and problem solving ability.
Excellent communication skills (written and verbal), along with leadership skills.
Knowledge of global clinical trial management. Ability to assemble a plan and execute on the details.
Apply project management best practices to programs. Experience in novel clinical drug development.
Protocol, ICF, CRF, CSR design and review.
Proficient with MS Office Suite (Excel, Word and PowerPoint) familiar with MS Project.

To find out more about Real Staffing please visit www.realstaffing.com
Start date
01/2013
From
Real Staffing
Published at
11.01.2013
Project ID:
470730
Contract type
Permanent
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