Job Summary

The 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 Responsibilities

• Assist 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 guidelines
• Assist 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 arise
• Develop and review informed consent forms, case report forms, study manuals, and other clinical trial materials
• Assist with evaluating, selecting, and managing clinical study sites
• Assist in the evaluation and management of CROs and other vendors; negotiate and manage contracts/budgets with CROs and other vendors
• Provide input to and manage project objectives to meet timelines and deliverables
• Provide routine study updates to the cross-functional operations team
• Analyze and develop action plans to address issues with investigational sites and/or CROs
• Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality
• Assist in training new team members on study processes, as required
• Responsible for tracking/maintaining study metrics/progress and updating Team
• Serve as sponsor primary contact for sites
• Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues
• Review and negotiate clinical site study contracts and budgets
• Plan, coordinate and present at Investigator Meetings and CRO Training meetings as requested
• Participate in site qualification, initiation, interim monitoring and close-out visits as needed; perform sponsor oversight visits to oversee and evaluate CRO site monitors
• Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings

Qualifications, Education & Experience

• Bachelor’s degree in a scientific discipline or health-related field
• Minimum of 2 years experience as a CRA in a biopharmaceutical company or CRO
• Previous experience with oncology clinical trials strongly preferred
• Experience working on early development trials a strong plus
• Radiopharmaceutical expertise a definite plus

Qualifications, Education & Experience

• Knowledge of FDA regulatory requirements and ICH/GCP guidelines
• Demonstrated proficiency in implementing, monitoring and management of clinical trials, from start-up to close-out
• Strong organizational skills, ability to prioritize and multi-task
• Excellent verbal and written communication skills
• Demonstrated problem-solving and negotiation abilities
• Ability to work as part of a team/active team participant
• Capacity to manage up and also roll-up sleeves when necessary
• Willingness to travel as necessary, consistent with project needs
• Excellent computer proficiency (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook)
• Experience with clinical trial databases (e.g., Medidata Rave, InForm, etc.).