Start Up Project Manager II - Serbia - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Start Up Project Manager (SUPM) , home-based and sponsor dedicated, in Serbia.In this role you will be responsible for defining, developing and delivering the global study start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required. The SUPM will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology. The responsibility of the SUPM typically ends when all investigative sites are activated and ready to enroll participants, however this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies. The SUPM will have a comprehensive knowledge of managing and coordinating study start up activities globally. The SUPM II will typically take full responsibility for medium to large size studies across all regions and countries, or for selected countries or region(s) of a global study where another SUPM is responsible for the site activations of the entire study. The SUPM II is the leader of the start up sub team for the study, region (s) or countries assigned.We are looking for hard-working, talented, high-caliber people. We know that employee satisfaction leads to customer satisfaction, which is the ultimate driver of long-term success.As the company that conducts vital clinical studies for sponsors, including the world's leading biotech’s and top 50 pharmaceutical companies, we offer you enormous security and long-term prospects.You will work from your home office base, supporting studies within their country or region. ‘Manageable sites, manageable protocols’ is our mantra. Expect exciting professional challenges in inspiring studies, but with time for your outside life.Accountability:Reports to Director/Sr Director of Start Up Project Management or Start Up Project Management Group LeadAll core study team members, SUPM acts as an ad-hoc member of the core study team throughout start up phase of a studyWithin CD&O: SUPMs, global study manager, study operations manager (study and country), site care partners, site activation partners, investigator contract lead, feasibility and site identification specialists, clinical trial assistants, clinical study team assistants, clinical study team leads, clinical operations planners, process and standards leads, quality management roles, clinicians and associated roles. Line managers of start up and study management rolesWithin PRD or POD: Regulatory submissions rolesProject Management:Partner with country / site feasibility specialists to incorporate up to date intelligence for the planned countries and sites into the overall start up strategy and site activation plan, most typically on studies with a medium to large country and site footprintPartner and co-ordinate across teams responsible for regulatory submissions (local and country) and start up functions (e.g. site essential document collection, site contracts and budgets) to align country and site activities, will have ability to form a robust start up strategy and site activation plan for operationally complex studiesThe SUPM is responsible for delivering site activations to plan, for the SUPM II this will generally be for studies with higher operational complexity (based on a combination of factors such study design, country and site footprint and the priority of the study). Responsibility can be for all sites for an entire study or a portion of sites in specific countries in one or more regionsAs part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many different roles working at the study and country level to oversee progress of the study specific (e.g. Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to completeProvide project management of activities directly required to complete all site activations for an assigned study as part of a study management led team to complete all start up activities for a studyLead start up meeti