Post: Country Approval Specialist - Mumbai - 130508
Job Description:
• Prepare, review and coordinate local regulatory and ethics committee submissions (and additional special national local applications if applicable for clinical trials) in alignment with global submission strategy for new and ongoing clinical trials
• Provide local regulatory submissions strategy advice (MoH & EC both) to internal clients and possibly to external client
• Provide project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments, may represent PPD to external client
• Primary contact for internal teams during discussion with investigators, site study team and with the local regulatory authorities (in collaboration with the local regulatory or startup manager for complex issues) to ensure submissions are managed in a timely manner
• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators (sites), and with the country regulatory authorities to ensure submissions are managed in a timely manner
• Act as a key-contact at country level for all submission-related activities
• Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
• Achieves PPD’s target cycle times (study startup timelines) for site activations
• Develop country specific Patient Information Sheet/Informed Consent form documents for the study and sites, obtains translations from translation vendor
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Support collection of trial commencement documents.
• Ensures that trial status information relating to SIA activities (study startup activities) are accurately maintained in the database (clinical trial management system) and is current at all times.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/ directives, and current regulatory guidelines as applicable to services provided
• Direct/mentor other Clinical and SIA individuals assigned to support projects of responsibility, as appropriate
• Preparation and maintenance of country master document templates and other PPD regulatory intelligence systems, as may be required and assigned
• Performs the function of mentor for junior clinical team members.
• Works in conjunction with the other Country Approval Specialist(s) and Contracts Specialist(s) to activate sites in timely manner.
• Represents PPD in the global medical research community and develops collaborative relationships with investigational sites and may assist with the feasibility process.
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and federal regulatory requirements/ audits.
• Provide feedback on country environment/sites for RFP, Bids and feasibilities
• Perform feasibilities for India and any other country as applicable
• Prepare, review and coordinate local regulatory and ethics committee submissions (and additional special national local applications if applicable for clinical trials) in alignment with global submission strategy for new and ongoing clinical trials
• Provide local regulatory submissions strategy advice (MoH & EC both) to internal clients and possibly to external client
• Provide project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments, may represent PPD to external client
• Primary contact for internal teams during discussion with investigators, site study team and with the local regulatory authorities (in collaboration with the local regulatory or startup manager for complex issues) to ensure submissions are managed in a timely manner
• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators (sites), and with the country regulatory authorities to ensure submissions are managed in a timely manner
• Act as a key-contact at country level for all submission-related activities
• Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
• Achieves PPD’s target cycle times (study startup timelines) for site activations
• Develop country specific Patient Information Sheet/Informed Consent form documents for the study and sites, obtains translations from translation vendor
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Support collection of trial commencement documents.
• Ensures that trial status information relating to SIA activities (study startup activities) are accurately maintained in the database (clinical trial management system) and is current at all times.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/ directives, and current regulatory guidelines as applicable to services provided
• Direct/mentor other Clinical and SIA individuals assigned to support projects of responsibility, as appropriate
• Preparation and maintenance of country master document templates and other PPD regulatory intelligence systems, as may be required and assigned
• Performs the function of mentor for junior clinical team members.
• Works in conjunction with the other Country Approval Specialist(s) and Contracts Specialist(s) to activate sites in timely manner.
• Represents PPD in the global medical research community and develops collaborative relationships with investigational sites and may assist with the feasibility process.
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and federal regulatory requirements/ audits.
• Provide feedback on country environment/sites for RFP, Bids and feasibilities
• Perform feasibilities for India and any other country as applicable
Qualifications
- Bachelor’s degree in a science related field or Pharmacy graduate or equivalent certification/licensure. In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.
- Previous experience as a study startup specialist or submission specialist that provides the knowledge, skills, and abilities to perform the job or completion of PPD Drug Development Fellowship.
- Having prior experience of site monitoring may be beneficial.
- Bachelor’s degree in a science related field or Pharmacy graduate or equivalent certification/licensure. In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.
- Previous experience as a study startup specialist or submission specialist that provides the knowledge, skills, and abilities to perform the job or completion of PPD Drug Development Fellowship.
- Having prior experience of site monitoring may be beneficial.
Additional Information:
Location: Mumbai - Maharashtra
Industry Type: Pharma/ Biotech/Clinical Research
Job Code: 130508
Location: Mumbai - Maharashtra
Industry Type: Pharma/ Biotech/Clinical Research
Job Code: 130508
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