Post: CPM- Senior Project Manager (SPM)
Emoluments & duration of assignment : Maximum up to Rs 1,10,000/- per month (One Year)
Location : CDSA Office, Faridabad
Job Description
• To oversee the management of a portfolio of trials/ studies including project management, quality monitoring and/or safety monitoring and guiding the study teams to achieve successful completion of all assigned activities in the project
• To support the Director CPM and other team leads in the implementation of systems for resource planning, study/trial administration and document management, data management and quality assurance.
• To contribute to research in design and conduct of trials/studies.
• Provides Leadership to: Project Manager/ Clinical Trial Manager, Senior Research Officer/ Research Officer, Clinical Research Associate/ Study Monitor, and Project/Clinical Trial Assistant.
• Has direct line management responsibility for upto 5 Project / Clinical Trial Managers
• Works Closely with: Project Team Members, Site Study team (Project Coordinator, Investigators), Expert groups/ Committee, Regulatory Affairs, Medical Affairs & Medical Writing, Data Management, Biostatistics, Central Laboratory, key Institute staff on finance, administration, contracts and personnel matters.
• External relationships: Investigators, Clinical collaborators, Sponsor counterparts
and management, third party contractors and regulatory authorities.• To oversee the management of a portfolio of trials/ studies including project management, quality monitoring and/or safety monitoring and guiding the study teams to achieve successful completion of all assigned activities in the project
• To support the Director CPM and other team leads in the implementation of systems for resource planning, study/trial administration and document management, data management and quality assurance.
• To contribute to research in design and conduct of trials/studies.
• Provides Leadership to: Project Manager/ Clinical Trial Manager, Senior Research Officer/ Research Officer, Clinical Research Associate/ Study Monitor, and Project/Clinical Trial Assistant.
• Has direct line management responsibility for upto 5 Project / Clinical Trial Managers
• Works Closely with: Project Team Members, Site Study team (Project Coordinator, Investigators), Expert groups/ Committee, Regulatory Affairs, Medical Affairs & Medical Writing, Data Management, Biostatistics, Central Laboratory, key Institute staff on finance, administration, contracts and personnel matters.
• External relationships: Investigators, Clinical collaborators, Sponsor counterparts
RESPONSIBILITIES AS LEADERSHIP AND STRATEGY:
• Support Director CPM on the development of systems for overseeing and reporting on clinical trials / studies and medical device portfolio
• Help develop mechanisms for prioritizing clinical trials/ studies for sponsorship
• 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, 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.
• Provide expert support to projects with regards to compliance, policy, sponsorship and high-risk studies
• Represent CDSA at regulatory inspections and meetings as required
• Support the Director CPM, collate project reports and write position papers as well as advising on “higher risk” studies and in the development of overall strategy
• 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. This will be done with the Administrative Manager
• 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
• Support Director CPM 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).
• Support Director CPM on the development of systems for overseeing and reporting on clinical trials / studies and medical device portfolio
• Help develop mechanisms for prioritizing clinical trials/ studies for sponsorship
• 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, 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.
• Provide expert support to projects with regards to compliance, policy, sponsorship and high-risk studies
• Represent CDSA at regulatory inspections and meetings as required
• Support the Director CPM, collate project reports and write position papers as well as advising on “higher risk” studies and in the development of overall strategy
• 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. This will be done with the Administrative Manager
• 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
• Support Director CPM 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 a portfolio of studies
• Organize meetings with clients (Investigators/ sponsor) to understand and negotiate the scope of the contract/ work and any Services Agreement in place for the client
• Prepare the Scope of Work for a assigned study/ trial
• Oversee preparation of initial budget for the project and support the finance department in preparation of budget for carrying out the assigned Scope of Work
• Review the Scope of Work with appropriate functional heads to identify staff necessary for the project team
• Prepare the project management plan, quality monitoring plan, safety monitoring plan, etc depending on the scope of work for the assigned study
• Support overall planning of the study with the investigator or team leading each project. Activities include but are not limited to early involvement in trial planning and budgeting, site level budgeting, site selection and evaluation, trial drug forecasting and negotiation with external providers, trial operational risk assessment, development of the data monitoring plan and trial team training.
• Input into study/trial protocols, informed consent forms, CRFs, and other trial related documentation
• Solicit expert advice, develop collaborative relationship with key experts and investigators
• Support the client/ investigator in preparing the dossier for submission to IEC/ regulatory agencies/ HMSC, etc
• Review and support the investigators to finalize responses to IEC/ regulatory agencies/ HMSC, etc
• Participate in clinical review meetings (teleconferences live meeting and or face to face) and document preparation meetings as required
• Provide input as necessary to Feasibility Studies, Data Safety Monitoring Committee (DSMC) and other committees, clinical/ product development planning meetings
• Provide or support project-related training as needed for team members
• Initiate the project following Best Practices in Project Management
• 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 progressing according to quality standards, SOPs, regulations, and guidelines
• Use project management plan as a 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
• Determine the cause of project overruns, discuss with line manager, recommend and institute corrective action, with input from functional Primaries
• Follow through on actions required
• Ensure the project is completed within the budget, schedule, and according to contract specifications
• Line manage project management staff within portfolio and manage with the Director CPM any performance management issues which arise with assigned staff
• Support the study/trial teams in their development, mentoring new trial and quality managers.
• Supporting the Director, CPM 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
• Revise SOPs or suggest process improvements for consideration.
• Support the Director, CPM in business development activities.
• Oversee a portfolio of studies
• Organize meetings with clients (Investigators/ sponsor) to understand and negotiate the scope of the contract/ work and any Services Agreement in place for the client
• Prepare the Scope of Work for a assigned study/ trial
• Oversee preparation of initial budget for the project and support the finance department in preparation of budget for carrying out the assigned Scope of Work
• Review the Scope of Work with appropriate functional heads to identify staff necessary for the project team
• Prepare the project management plan, quality monitoring plan, safety monitoring plan, etc depending on the scope of work for the assigned study
• Support overall planning of the study with the investigator or team leading each project. Activities include but are not limited to early involvement in trial planning and budgeting, site level budgeting, site selection and evaluation, trial drug forecasting and negotiation with external providers, trial operational risk assessment, development of the data monitoring plan and trial team training.
• Input into study/trial protocols, informed consent forms, CRFs, and other trial related documentation
• Solicit expert advice, develop collaborative relationship with key experts and investigators
• Support the client/ investigator in preparing the dossier for submission to IEC/ regulatory agencies/ HMSC, etc
• Review and support the investigators to finalize responses to IEC/ regulatory agencies/ HMSC, etc
• Participate in clinical review meetings (teleconferences live meeting and or face to face) and document preparation meetings as required
• Provide input as necessary to Feasibility Studies, Data Safety Monitoring Committee (DSMC) and other committees, clinical/ product development planning meetings
• Provide or support project-related training as needed for team members
• Initiate the project following Best Practices in Project Management
• 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 progressing according to quality standards, SOPs, regulations, and guidelines
• Use project management plan as a 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
• Determine the cause of project overruns, discuss with line manager, recommend and institute corrective action, with input from functional Primaries
• Follow through on actions required
• Ensure the project is completed within the budget, schedule, and according to contract specifications
• Line manage project management staff within portfolio and manage with the Director CPM any performance management issues which arise with assigned staff
• Support the study/trial teams in their development, mentoring new trial and quality managers.
• Supporting the Director, CPM 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
• Revise SOPs or suggest process improvements for consideration.
• Support the Director, CPM in business development activities.
QUALITY MONITORING:
• Work with investigators/ sponsor prior to start of project on incorporation of quality management processes into the scientific and operational design of the trial
• To offer support to investigators/ sponsor to ensure compliance with applicable regulations and policies;
• Oversight of safety data processes within the portfolio
• Develop a monitoring plan with project investigators that is tailored to the specific human subject protection and data integrity risks of the trial
• Agree predefined quality tolerance limits to identify systematic issues that can impact subject safety or reliability of trial results
• Provide advice and support for site feasibility
• Oversight for quality monitoring as per the approved plans.
• Visit sites and participating institutes as and when required
• Work with investigators/ sponsor prior to start of project on incorporation of quality management processes into the scientific and operational design of the trial
• To offer support to investigators/ sponsor to ensure compliance with applicable regulations and policies;
• Oversight of safety data processes within the portfolio
• Develop a monitoring plan with project investigators that is tailored to the specific human subject protection and data integrity risks of the trial
• Agree predefined quality tolerance limits to identify systematic issues that can impact subject safety or reliability of trial results
• Provide advice and support for site feasibility
• Oversight for quality monitoring as per the approved plans.
• Visit sites and participating institutes as and when required
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