Roles and Responsibilities Ensure that study activities and milestones are planned, agreed and achieved according to the overall clinical development plan (CDP, if applicable), and the corresponding milestone and recruitment plans Determine the feasibility for running a clinical study in collaboration with other functions as required. Responsible for the timely and accurate preparation of study documentation such as protocols, amendments, case report forms (CRF)/e-CRFs, study plans and study reports in collaboration with other functions and CROs as required. Ensure that the appropriate Regulatory and Ethics Committee submissions and approvals are obtained. Ensure that (Serious) Adverse Event ((S)AE) reporting is performed in compliance with internal and external (S)AE reporting requirements. Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO. Participate in the selection of Services Providers /CROs and other external vendors in collaboration with sourcing department / Strategic Alliances Director and study team. Select (in collaboration with other functions), supervise and actively manage contractors, consultants and external vendors being part of the clinical study, e.g. Central Lab, EDC vendor, Clinical Research Organization (CRO), ECG vendor, etc. as needed. Build strong relationships to maximize performance and value delivered by Service providers Create a culture of joint accountability to ensure Vendor performance Facilitate efficient and collaborative resolution of problems and conflicts with Service Providers Facilitate vendor training on applicable GEHC SOPs Perform initial contact and participate in the assessment and selection of qualified investigators for inclusion in clinical programs. Oversee performance of Pre-Selection, Initiation, Monitoring, and Closeout site visits. Oversee negotiation and tracking of site budget according to financial agreement with each site Oversee the tracking of subject enrollment at each trial site and provides management with reports of clinical activities, as requested Ensure that clinical trial sites have adequate supplies to perform the trial May supervise the work of less experienced study managers Manage Clinical Study budget Attend monthly Clinical Research Meeting to report on progress of their assigned study/ies Participate in the development and review process of globalization and harmonization such as Standard Operating Procedures, guidelines, and forms. Identify and communicate areas for improvement within local and global Clinical Research infrastructure at GEHC In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks. Make sure daily operation of clinical study is in line with QA system and regulation, and ensures the project team maintains a continuous state of audit readiness. In collaboration with the Medical Director, identify study committee members (such as steering committee, publication committee), ensure contracts and charters in place and ongoing oversight and management is performed. Attend Competent Authority/Ethics Committee study review meetings as required. Required Qualifications . Degree in a science related field with proven extensive experience of complex clinical phase 1 – 4 study management within the healthcare industry Excellent prior knowledge of all aspects of the clinical study process including planning, execution and reporting/publication of results Proven communication skills, both written and verbal, at all levels of an organization Desired Characteristics Excellent written and oral communication skills, interpersonal skills and good presentation skills Well organized and structured, attention to detail Ability to work independently and systematically Diplomatic, cooperative team worker Decisive attitude Proven ability to manage complex studies and/or multiple studies across different regions Proven leadership skills Must be willing to travel as required, for study team meetings, site visits, client presentations and other professional meetings/conferences as needed. Have a flexible approach
