Opportunity for Clinical Research Manager at Excel Lifesciences
Excel Life Sciences (ELS) is a U.S.-based, India focused, provider of comprehensive clinical trial management services, focusing on site performance, patient enrollment and on-time study completion.
ELS’ success is built around passionate and experienced individuals working alongside our clients to accelerate clinical research and deliver new drugs and medical devices to the markets, while maintaining the highest standards of quality. As a trial management organization, we are also committed to improving and expanding the clinical research enterprise in India, evident through our presentations at conferences, peer-reviewed publications, and continuing relationships with academic institutions.
Post: Clinical Research Manager
I. Essential Functions:
Provide overall management of clinical trials or clinical programs. General areas of responsibility include:
Sponsor liaison, project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to contract and quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communication between project team, Sponsor, contract and financial management.
• Manage international projects. May be part of a global project management team.
• Participate in proposal development teams, giving input to particular indication and operational structure for the proposal.
Reports To: Line Manager who may be Director Operations
External Relationships: Sponsor counterparts and management, investigators, third party contractors, regulatory authorities.
• Take primary responsibility for Sponsor relationship and Sponsor communication ensuring high Sponsor satisfaction.
• Project Initiation and Planning
• Organize a meeting with Account Management/PDG to understand the scope of the contract and any Master Services agreement in place for the Sponsor.
• Review the project contract exhibit and send it for information to the Functions involved in the project or make sure that the Functions have received it from another source and request resources from appropriate functional heads.
• Develop a project plan, including all elements listed in the project plan template as appropriate for the project (Roles and Responsibilities, WBS, Communication Plan, Risk Analysis, Contingency plan etc).
• Review initial budget split provided by Contracts, request for study specific adaptations and develop Revenue Recognition Tool for the project.
• Ensure information entered into management systems
• Provide or arrange for project-related training as needed for team members.
• Project Implementation, Control and Evaluation
• Ensure the project is completed within budget, schedule and according to contract specifications.
• Ensure the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations.
• Ensure information entered into management systems is accurate and updated on a regular basis.
• Hold end of phase meetings to review lessons learned.
• Take primary responsibility for the response to project audit findings specific to the project.
• Manage the budget including the completion of monthly revenue recognition with the Financial Analyst, forecasting and cost management.
• Manage the project pro actively, anticipating problems and providing resolutions in a timely manner.
• Ensure the communication to team members of the scope of work, timeline and project goals, technical information, and input from Sponsor throughout the project.
• Ensure the communication to the Sponsor of timeline and project progress, the results of risk analyses, contingency plans, technical information, and input from team throughout the project. Also, any significant changes in resourcing, scope of work and timelines.
• Inform team members of any new information or modification of project-related issues that may affect specific responsibilities of team members.
• Provide Line Manager with input regarding team members’ performances as needed for employees’ periodic performance review.
• Ensure all administrative closeout procedures are completed, according to Project Closeout Checklist.
• Ensure project is archived and all documentation returned to Sponsor as specified the by the contract.
• Independently develop, manage, execute, and own overall project plan and timelines for key deliverables
• Lead and manage project team to ensure timely and effective completion of project assignment and other tasks
• Direct implementations and serve as primary client contact on implementations
• Establish clear definition of clients' implementation responsibilities and company's responsibilities with each client
• Establish a clear understanding of client's key metrics prior and determine clear quantifiable expectations for the customer once fully implemented
• Perform general practice, workflow, and staffing assessments of prospective client organizations
• Collaborate in the ongoing development of the implementation process and other client services the team provides
• Collaborate in the ongoing development of training materials and curricula
• Organize and lead training sessions
• Administer end user proficiency tests
Highly matured candidate with the desired experience, Positive Attitude, Excellent written and verbal communication, Good analytical skills, Team player, Good managerial skills etc.
Experience: 4-7 years
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Production
End Date: 16th June, 2011
Apply/Send resume at, email@example.com, firstname.lastname@example.org
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