Study Start Up Project Leader - Home based ItalyDescriptionCome discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.Why Syneos Health - #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. - We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.Brief Description of Position:Accountable for execution and oversight of local operational clinical trial activities in a country forAssigned protocols in compliance with ICH/GCP and country regulations, policies and procedures,Quality standards and adverse event reporting requirements internally and externally.Specific responsibilities include, but are not limited to:Ownership of country and site budgets. Development, negotiation and completion of Clinical TrialResearch Agreements (CTRA).Oversight and tracking of clinical research-related payments. PaymentReconciliation at study close-out. Oversight of FCPA, DPS/OFAC, and maintenance of financial systems.Financial forecasting in conjunction with CRD.Responsible for execution and oversight of clinical trial country submissions and approvals for assignedProtocols. Development of local language materials including local language Informed Consents andTranslations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.Responsible for managing country deliverables, timelines and results for assigned protocols to meetCountry commitments. Responsible for quality and compliance in assigned protocols in country.Contributes to the development of local SOPs. Oversees CTCs as applicable.Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure countryDeliverables are obtained for submissions, budgets, CTRAs and local milestones. Collaborates closely withRegional Operations to align country timelines for assigned protocols. Provides support and oversight toLocal vendors as applicable.Oversight and coordination of local processes. Clinical and ancillary supplies management, importing andExporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retentionRequirements, and insurance process management. Enters and updates country information in clinical andFinance systems.Has ownership, oversight and impact on local regulatory and financial compliance. The position has aSignificant impact on how a country can deliver country-specific trial commitments and objectivesEspecially during study start-up.Working closely with the CRD and local GCTO country operation to assess, prioritize and drive executionOf specific clinical trials in order to support and manage the pipeline and local business needs to agreedTimelines and budgets. Required to in/directly influence investigators, external partners and countryOperations to adhere to budget targets and agreed payment timelines.Works in partnership internally with GCTO country operations, finance, regulatory affairs,Pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors andSites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. ThroughContinual interaction with local clinical team/s successfully delivers clinical and financial contracts withinFair market value.QualificationsQualifications, Skills & Experience - Bachelor's Degree (or comparable) in Business Finance/ Administration/ Life Science or equivalentHealth Care related experience - 5-7 years clinical research experience - Requires expertise of core clinical systems, tools and metrics - Excellent English skills required - Strong coordination and organizational skills required - Requires skilled knowledge of budget and contract negotiations, local regulatory environment andSubmission and approval processes, and understanding of how these impact study start-up. - Able to indirectly influence investigators, vendors, external partners and country managers toAddress and resolve issues, with minimal support from the CRD. - Requires ability to make decisions independently with limited oversight from CRD. Able to manageImportant activities relevant to clinical research activities in the country according to predeterminedGlobal policies and commitments. Requires strong understanding of local regulatory environment forThe individual to weigh pros and cons of key decisions with input from manager. - Problem solving is essential to this position. Requires the ability to pro-actively identify issues andRisks, analyze root cause, and propose solutions to problems and escalate to management asApplicable. Specific examples of common problems include: 1) Issues in budget / CTRA negotiations,2) Quality and compliance issues, 3) Regulatory and legal issues, and 4) issues related to functionalArea deliverables that could jeopardize protocol milestones. - Position requires extensive experience in clinical research operations and experience with projectManagement and coordination. - Expertise of core clinical, regulatory and financial systems, tools, metrics and local requirements isEssential. - Strong communication, leadership, and negotiation skills as well as excellent influencing andTraining/mentoring skills, both written and verbal, in local language and English. - The ability to focus on multiple deliverables and protocols simultaneously is essential. Requires thatThe individual has ability to work effectively also in a remote virtual environment with a wide range ofPeople. - Additionally for financial responsibilities: Background in business finance is preferred and strongKnowledge and aptitude in accounting and financial procedures. - Ability to proactively develop risk management and mitigation plans in the country and resolve issuesLocally.Create a job alert and receive personalised job recommendations straight to your inbox.#J-18808-Ljbffr
