Manager CDC

Job Description

Roles and ResponsibilitiesPurpose of the jobResponsible for Project planning and people management for assigned trial/research project/s for the CDC, and ensuring deliverables are met as per project timelines, within budget and complying with Protocol, regulatory requirements, Helsinki Declaration, GCP (Good Clinical Practice) and SOPs (Standard Operating Procedures). Manage and coach CTAs and Project Managers.Position s key accountabilities- Lead quality clinical trial projects (CDP and/or local) in the CDC (40%)- Provide trial related communication and insight to key internal and external stakeholders (25%)- Develop PMs and CTAs and implement necessary actions to improve their performance (20%)- Coordinate the clinical trial set-up in partnership with the COM (15%)Other responsibilities and duties which may be required depending on priorities; in this case the established percentages should be updated.Nature and scope of Main accountabilities in the CDC and adjacent affiliates- Lead quality clinical trial projects (CDP and/or local) in the country- Track tasks performed by team members ensuring timely and effective execution of local clinical trials.- Ensure that budgets are managed in line with the plan and together with LTM update the study budget if required.- Monitor that submissions / approvals are performed in time and appropriately. Review key regulatory documentation ensuring it complies with requirements.- Develop the study specific quality plan and ensure protocol execution and compliance.- Co-monitor visits, in partnership with the COM, monitor the quality of the clinical trial execution, quality audits and inspection issues.- Check the maintenance of the TMF (Trial Master File) to ensure compliance.- Proactive risk management and escalation of issues/risks for the assigned trial - Collaborate in site closure.- Provide trial related communication and insight to key internal and external stakeholders- Ensure that all data pertaining to the study status is compiled and reported.- Represent CDC countries in the relevant ISGs- Provide key operational information to the AAMEO COM, RTM, IO TA COM and update them on the clinical trial progress, elaborating reports when necessary.- Point of contact for global trial management teams (e.g. ITMs) on behalf of CDC- Provide vendors and external clients with timely project status information.- Provide input to develop materials for local Investigator Meetings and monitor Training Meetings if applicable.- Maintain ongoing communication with Ethics Committees and the Health Authority, ensuring the Central and local (as applicable) Ethic Committee is provided with the documents requested.- Develop team members and implement necessary actions to improve their performance- Ensure that staff is appropriately trained for the roles they are undertaking. Identify training needs and coordinate the necessary training for them- Appraise performance for PMs and CTAs - Define PMs and CTAs individual development plan. Provide them with new challenges and/or responsibilities in alignment with Novo Nordisk business needs. Together with the COM follow up on team members personal and professional development. - Coordinate the clinical trial set-up in partnership with the COM- Coordinate CDC level protocol feasibility test together with the COM.- Identify sites, coordinate site assessments (if required) and elect appropriate sites to allocate local clinical trials liaising with the COM and MMs.- Negotiate Clinical Trial Agreements with local Investigators and monitor the relevant payments- Plan local studies and, together with the COM, assign LTM.- Provide input to the protocol, Case Report Form (CRF) design, monitor s manual and other trial related documents.- Assist LTMs in the preparation and carry out of pre-study and/or initiation visits.- Collaborate with the COM in effective site recruitment, providing the necessary criteria for successful staffing. - Ensure timely execution of contracts in partnership with the LTM.- Constantly network among institutions and academicians to identify good centres for clinical trials.Purpose and subject of interaction with internal/external customers and key contactsExtensive and proactive communication both internally and externally is essential for successful implementation of main accountabilities.The position requires effective people management to develop and lead the project group. Geographically distributed responsibilities between India, Malaysia and Thailand.,

Keyskills :
comregulatory documentationpeople managementexternal clientstrial managementproject planningrtmtmfquality audittraining needsindividual developmentrisk managementpmsgcpregulatory requirementsclinical trialclinical trialscdcstatements