Job Background Chiltern is the leading, global mid-sized contract research organization.
We listen to client needs to deliver customized clinical development solutions with a team of more than 4,300 working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include clinical development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision. Chiltern is looking to recruit a Start Up and Contract Manager office based in Lisbon to be dedicated to one of our sponsors, a global pharmaceutical company. Coordinates guides and assists with all start up activities prior to site activation, including but not limited to: - For global studies, prepare Country-Specific Informed Consent Form (ICF) in line with regulatory/health authority requirements - Ethics Committee and Health Authority information, meeting dates & costs - Ethics and Health Authority applications & associated online systems - Ethics and Health Authority submission processes - Ensure Ethics Committee and Health Authority requests, questions and comments are addressed - Contracts & Indemnity request process, namely contract negotiation with sites and obtain insurance certificates Prepares ongoing submissions, amendments and periodic notifications required by Ethics Committees and Health Authority as need within the country. Maintain up to date knowledge and compliance adherence with local regulatory requirements and associated documentation. Review, analyze and collate metrics to ensure processes that drives efficiency and reduction of timelines across start up and contracts negotiation are in place. Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams Assist with Investigational Medical Product (IMP) label preparation and approval (local label representative) for studies in collaboration with local regulatory department. Track metrics and study start-up timelines to identify trends and opportunities for improvement. Manages end-to-end contract work flow within the Clinical Operations Department: - Define and manage the local Clinical Operations Contract Management end-to-end process including indemnification activities if applicable. - Ensure themselves, or through others, that all appropriate and required internal reviews and approvals are obtained for clinical contracts. - Ensure execution of approved and finalized contracts, including provision of all required information from internal study staff and timely hand off to other internal partners / stakeholders. - Ensure contracts are maintained in the appropriate internal systems. - Has oversight of contract negotiation/approval timelines/metrics and provides performance metrics to the Clinical Operations leadership group. - Shares best practices, recommending opportunities for continuous improvement, training and operational excellence. - Prepares and delivers structured training materials with regards to the Contracting process to local Clinical Operations staff as required. Maintains overview of nature of site contracts, including any changes made to the site specific template held with sites and key partnerships. Relationship/Strategy management: - Liaise and collaborate with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches. - Maintain currency and awareness of changes in Start Up processes across government, hospital & industry & liaise with stakeholders to resolve any SSU issues. - Proactively respond to information survey requests by government / industry bodies. - Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities. - Maintain communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met. - Provide guidance to CSMs and CSS on regulatory/ethics, track & drive site activations and trial amendments submissions, by regular review and monitoring status of submissions/activations. - In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process. - Liaise and share best practices with other SSUS within the region/organization. New Site Identification: - Assist with identification and tracking of new sites in collaboration with CSMs Contracts/Budget: - Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization. - Provide local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country. - Collaborate with CSMs to maintain data to ensure FMV. - Works with the CSM, taking the lead in coordinating the negotiation and gaining necessary approvals for clinical contracts when required. - Acts as central point-of-contact for all contract discrepancies and questions including the provision of timely responses to internal customers (project/study teams, Legal Department and other internal partnerships) and external customers (Sites, Investigators and other external partnerships) to resolve and expedite contract issues. - Helps ensure maximum return on investments and customer satisfaction for all contract responsibilities. Provides support to Globally Outsourced Studies Contracting Process (as required by local law): - When requested by globally outsourced partner provide advice and assistance, including provision of support from Country Head, other Clinical Operations staff and/or local Legal/Finance Dept, to facilitate the timely approval of site contracts in this study model. Requirements: University Degree or Equivalent preferably in a medical/science-related field Demonstrated knowledge and understanding of ICH-GCP/GPP, the regulatory, ethics and contractual requirements for starting clinical trials in the country. Demonstrated competence in analysis, planning and problem solving. Excellent communications skills including the ability to state opinions clearly, ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English Experience working as part of a team with a proven ability to make an active contribution to the team’s performance and teamwork Able to make effective decisions, self-motivated, assertive, and displays initiative Proven project management and organizational skills and the ability to prioritize and manage multiple tasks with flexibility Demonstrated computer literacy, usage of MS Office software, web-based systems and databases. Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans. Salary On application Position Type Permanent Full Time Contact Email Kevin Thomas - ********** +33 01 41 05 73 53
Ciudad: portugal
