Sr. Study Management Associate

Job SummaryThe Sr. Study Management Associate/ Study Management Associate, Clinical Operations (Sr. SMA/SMA) will report to the Head of Clinical Operations and will be responsible for assisting in the oversight and management of clinical trial execution. The Sr. SMA/SMA will maintain oversight over CROs and key study CSPs to ensure quality conduct of trials and data collection and work closely with study sites/investigators. The Sr. SMA/SMA will also work cross-functionally with other groups such as Clinical Development, CMC/Supply Chain, Regulatory Affairs and Project Management.Principal ResponsibilitiesAssist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelinesAssist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, etc) and proactively identify solutions within the clinical team when issues ariseDevelop and review informed consent forms, case report forms, study manuals, and other clinical trial materialsAssist with evaluating, selecting, and managing clinical study sitesAssist in the evaluation and management of CROs and other vendors; negotiate and manage contracts/budgets with CROs and other vendorsProvide input to and manage project objectives to meet timelines and deliverablesProvide routine study updates to the cross-functional operations teamAnalyze and develop action plans to address issues with investigational sites and/or CROsAssist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data qualityAssist in training new team members on study processes, as requiredResponsible for tracking/maintaining study metrics/progress and updating TeamServe as sponsor primary contact for sitesParticipate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issuesReview and negotiate clinical site study contracts and budgetsPlan, coordinate and present at Investigator Meetings and CRO Training meetings as requestedParticipate in site qualification, initiation, interim monitoring and close-out visits as needed; perform sponsor oversight visits to oversee and evaluate CRO site monitorsSupport internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findingsQualifications, Education & ExperienceBachelor's degree in a scientific discipline or health-related fieldMinimum of 2 years experience as a CRA in a biopharmaceutical company or CROPrevious experience with oncology clinical trials strongly preferredExperience working on early development trials a strong plusRadiopharmaceutical expertise a definite plusQualifications, Education & ExperienceKnowledge of FDA regulatory requirements and ICH/GCP guidelinesDemonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-outStrong organizational skills, ability to prioritize and multi-taskExcellent verbal and written communication skillsDemonstrated problem-solving and negotiation abilitiesAbility to work as part of a team/active team participantCapacity to manage up and also roll-up sleeves when necessaryWillingness to travel as necessary, consistent with project needsExcellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook)Experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.).

Created: 2024-11-02