Clinical Development Services Agency (CDSA) has therefore been formed as a not-for-profit society to provide supportive and focused environment to host world class clinical translation through a collaborative network of clinical investigators and premier research institutions.  It will tend enterprises, particularly SMEs involved in new technology innovation, to facilitate translation of scientific know-how into viable products for public health diseases like malaria, tuberculosis and dengue among others.

Post : Director Clinical Portfolio Management

Age Criteria : Up to 45 years

Emoluments : Up to Rs. 1,25,000/- per month consolidated

Duration : One year and likely to be continued

Location : CDSA, Faridabad

Responsibilities
A. Leadership and Strategy
• Support the CDSA Director in the development of overall strategy
• Contribute to developing the clinical trials/studies portfolio
• Lead on the development of systems for overseeing and reporting on clinical trials / studies and medical device portfolio (including mechanisms for prioritizing clinical trials/ studies and for ensuring full cost recovery and income generation).
• Analyze and formally report data and information on trends related to research sponsorship activities
• Ensure consistent application of core CDSA policies and operating procedures across the CDSA sponsored trials/ studies portfolio
• Act as the lead on behalf of CDSA for projects and committees, meeting with internal and external partners (academic and industry collaborations, vendors, sponsors and manufacturers and regulators)
• Continually review and respond to changes required to shape the infrastructure, functionality and standards of clinical trials/ studies management, including the development and implementation of systems, operating procedures and policies.
• Effect change and/or ensure dissemination of regulatory effective change management systems are implemented to facilitate the changing clinical trials management environment in India and CDSA, in particular the operational implications of new clinical trials and CDSCO/ ICMR regulations and policies.
• Provide expert support to projects with regards to compliance, policy, sponsorship and high-risk studies

• Represent CDSA at regulatory inspections and meetings as required
• Act as a key advisor on regulatory matters, collating project reports and writing position papers as well as advising on “higher risk” studies
• With the Administrative Manager and Consultant Regulatory Affairs, oversee and draft Memorandum’s of Understanding (MoU’s) or other documents to outline the delegation of duties from the sponsor office to CDSA and other stakeholders of the projects
• Actively contribute to or lead on initiatives related to the development of CDSA including resourcing, skills and training, systems and aligned risk assessments and strategies
• Lead for escalations and trouble shooting where issues or concerns are raised by researchers with regards to trials and “higher” risk studies
• Ensure the dissemination of information for CDSA staff on the CDSCO/ ICMR Clinical Trials Regulation and its implications, regulatory requirements, research governance and Good Clinical Practice (GCP).

Operations Management
• Oversee the preparation of client proposals
• Participate in business development activities.
• Participate in clinical review meetings (teleconferences live meeting and or face to face) and document preparation meetings as required
• Solicit expert advice, develop collaborative relationship with key experts and investigators
• Organize meeting with Client to understand the scope of the contract and any Master Services agreement in place for the client
• Review the Project contract exhibit with appropriate functional heads to identify staff necessary for the project team
• Develop project plan, including all elements listed in the project plan template as appropriate for project (Roles & Responsibilities, Communication Plan, Risk Analysis etc.)
• Oversee preparation of initial budget for the project
• Review and finalize responses to IEC and regulatory agencies
• Responsible for reviewing study protocols, investigator's brochure, clinical study reports, IND sections
• Revise SOPs or suggest process improvements for consideration. May draft new SOPs for review and act as reviewer for Clinical SOPs, as assigned and appropriate.
• Provide input as necessary to Feasibility Studies, Data Safety Monitoring Committee (DSMC) and other committees, clinical/ product development planning meetings

• Provide or arrange for project-related training as needed for team members
• Initiate the project following Best Practices in Project Management
• Ensure the project is progressing according to quality standards, SOPs, regulations, and guidelines
• Use project plan as a management tool to record and measure progress, updating as necessary
• Track resources and actual time spent on each project task for all team members to evaluate project progress and profitability
• Review metrics reports regularly and follow through on actions required
• Determine the cause of project overruns, recommend and institute corrective action, with input from functional Primaries
• Attend and represent project management/ contracted services at internal meetings and investigator meetings
• Ensure information entered into management system is accurate, and updated on a regular basis
• Ensure the project is completed within the budget, schedule, and according to contract specifications
• Takes a leading role in preparing or contributing to the production of any type of clinical document, for either internal CDSA customers or external clients, for investigational drugs, biologicals, or medical devices
• Provide consulting services to assist in the development of new drugs or devices under the direction of the Head of Organization

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