Clinical Trial Manager

This position will be on-site in one of the following locations: San Francisco Bay Area / Dallas, TX / Miami, FL

*Relocation support will be considered for this role

Overview of Role

:Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial

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Role and Responsibilitie

• s:Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are m
• etInitiates and builds solid professional relationships with key opinion leaders and clinical site sta
• ffPartners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on ti
• mePartners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality da
• taProactive identification and management of study related ris
• ksResponsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreemen
• tsResponsible for reviewing and managing study related plans, processes includi
• ngInvestigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitori
• ngResponsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be m
• etReviews and approves essential document packages to enable timely site activatio
• nsReviews pre-study, study initiation, interim monitoring visit and at study closeout visit repo
• rtProvides close oversight on the findings on the monitoring reports and loops back with broader team to provide updat
• esDirects investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessa
• ryResponsible for oversight on the maintenance of the TMF and completeness at the end of the stu
• dyPerform periodic QC of the T
• MFOversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SO
• PsEnsures the study is “inspection ready” alwa
• ysResponsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the proje
• ctAll other duties as assign

edExperience, Education and Specialized Knowledge and Skill

• s:Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferr
• ed5 years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organizati
• onPrior phase II and III experience requir
• edA solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial proce
• ssExperience with budget forecasting and manageme
• ntExperience with clinical studies in oncolo
• gyAbility to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20
• %)Proven proficiency in overseeing large complex studies being managed in house and by a C
• RODemonstrated ability to lead teams and work in a fast-paced team environme
• ntExperienced and enjoys building relationships with KOLs and site personn
• elAbility to successfully engage and work collaboratively with overseas clinical operations team members/colleagu
• esDemonstrated ability to build and deliver on patient enrollment strategi
• esExcellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectiv
• esDemonstrated ability to comprehend complex scientific concepts and da
• taProficient in reviewing and assessing clinical da
• taPossesses excellent planning, time management & coordination skil
• lsDemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical progra
• msExperience in working in a small organizati
• onExcellent written and oral communication skil

lsThe pay range for this role is $118,500 to $139,500 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensatio

n.
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