Manager, Study Activation
2 settimane fa
START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START’s mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population – leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many – by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. We are hiring a Manager, Study Activation (Remote) who is responsible for managing and coordinating activities and activation deliverables related to initiating a clinical trial. This role will lead all pre-award and start-up activities including site selection, activation, and preparation for patient enrollment. This role provides direction and oversight to the Pre-Award and Study Start-Up teams. This is a remote role. The annual base salary for this role is $100,000 - $125,000 + Bonus. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. Essential ResponsibilitiesSupport Study Start Up (SSU) strategy in close collaboration with the VP, Client Engagement & Study Activation. Collaborate with central services and site-level study team to ensure SSU timelines and deliverables are met according to internal process, KPIs, and Sponsor goals. Manage the timely start-up activities until Green Light (ready to initiate site milestone). Support and direct study feasibility and site selection milestones in close collaboration with Pre-Award Coordinator as well as the site-level study team. Support and direct study activation milestones in close collaboration with Study Start-up Specialist as well as the site-level study team. Serve as main contact for issues in pre-award and SSU phases, escalating as necessary. Ensure sites are prepared for “Green Light” and ensure all documentation is in place for initial and subsequent drug release. Review and sign off of the site “Green Light”. Oversee pre-award & SSU team activities to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to START standards. Leads US SSU team meetings and participates in network study team meetings, as required. Contribute to the growth and development of departmental staff, processes and systems. Embrace HubSpot, Veeva Vault, FileMaker, and CTMS system and associated functionality and maintain records related to specific area of assignment. Assist with in-service trainings and new hire trainings for staff. Assist with special projects as assigned. This includes, but is not limited to, conducting research, preparing presentations and documents as requested. Education & ExperienceBachelor’s Degree and/or appropriate experience from the Medical/science background and/or related discipline. 5+ years of experience in clinical research. Skilled in management and fostering a collaborative work environment. Project management experience and demonstrated role in developing others. Strong oral and written communication skills. Preferred Education And ExperienceSenior/Lead clinical research role at a CRO in Study Start-Up. Physical & Travel RequirementsTravel: Required to travel up to 10% of the time. Approximately 80% of time is spent sitting. Frequent and repetitive use of keyboard, mouse, and computer. Best-in-Class Benefits And PerksComprehensive health coverage: Medical, dental, and vision insurance provided. Robust retirement planning: 401(k) plan available with employer matching. Financial security: Life and disability insurance for added protection. Flexible financial options: Health savings and flexible spending accounts offered. Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided. More About The START Center For Cancer ResearchDeeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. #J-18808-Ljbffr
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