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