Job details
Job type contract
Full job description
Premier research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional clinical trial manager to bring your passion to our teamYou will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniorityMost importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At premier research, we are science-minded and heart-centeredJoin us.
As a clinical trial manager, you will be: responsible for assisting sites in the transition of patients from active clinical trial status to end-of-trial access drug programs, including open-label and commercial productYou will support assigned studies in collaboration with global study team members, by executing administrative functions such as minute taking, data entry, tracking, binder creation, and supply distributionAlso responsible for participation in study meetings, essential document review, and trial master file (tmf) processingMay also participate in budget negotiation, fee tracking, and amendment processing in accordance with protocol, standard operating procedures, international organization of standardization (iso)/good clinical practices (gcp) and other applicable regulatory requirementsProvides support in start-up, enrollment, follow-up and closure of clinical trial activities.
Role responsibilities:
Assists sites in transitioning patients from the clinical trial to subsequent access programs, including commercial product access
Participates in clinical research organization/vendor selection process
Oversees vendor activities including reviewing monitor visit reports, participating in vendor meetings, supporting development and management of vendor oversight plans/trackers, and identifying and mitigating escalating issues or risks as appropriate
Manages and oversees site start-up, subject recruitment, enrollment, study management, monitoring, site management, trial master files (tmfs), and data cleaning
Participates in the design of case report forms (crfs) and the development of project plans and clinical reports
Proactively identifies potential study issues/risks and recommends/implements remediation
Supports the management of study related activities including timelines, study visits, site selection, site initiation, site management, study drug management, closeout activities, trackers, and data sharing forums
Assists in the development, review and approval of regulatory documents, as well as all other required study documents, in a manner that is gcp compliant
Manages ongoing communication of operational issues and provides accurate progress reports on assigned activities to study team
Responsible for managing site and/or vendor budgets
Participates in and manages quality data cleaning activities, such as data listing reviews
Participates in and facilitates project team discussions and meetings.
Leads and/or participates in quality improvement and process improvement initiatives.
Performs additional duties as assigned
Requirements:
Bachelor’s degree, or international equivalent from an accredited institution, preferably in a technical, clinical, or health-related field, or equivalent combination of education, training and experience
3 to 5 years of study management (or equivalent) experience in clinical and drug development
Must have experience in access drug programs
Proven experience in managing specialty labs and outside vendors
Strong leadership skills; ability to build and motivate teams to achieve results; ability to influence and inspire action through strong decision-making skills
Demonstrates excellent english verbal and written communication
Excellent computer skills in a microsoft windows environment including proficiency in the microsoft office suite of tools (e.g., outlook, work, excel, etc.)
Proven ability to drive a successful customer experience through positive customer interactions, provision of quality and timely deliverables, and task ownership
Strong analytical and organization skills; able to work independently and manage multiple projects simultaneously in a fast-paced environment with changing priorities
Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment
