
Working with Us
Supports study execution utilizing available performance metrics and quality indicators
May oversee clinical monitoring quality and adherence to established processes and plans
Supports/manages discrete study deliverables (i.e., timelines, study plans, CTMS, etc.) through collaboration with internal and external stakeholders to inform robust data driven decisions
Proactively identifies potential risks, support Global Trial Lead (GTL) leading study in development/implementation of actions, and contributes to discussions on appropriate trade-offs of balancing risks with study deliverables and costs. In situations where Principal GTA is the lead of a study, they will manage development and implementation of actions associated with identified risks.
Solves routine problems/issues; escalates to GTL or other related functions as needed
Informs lead GTL and other leadership (as appropriate) on overall clinical trial plans and of potential issues/mitigation
Exposure to situations where benefit-risk and issues assessments need to be managed
Supports creation and implementation of project management tools at study level (issues log and risk management plan – drives tool maintenance
Manages the development/set-up and/or collection of study level documentation and support GTL in ensuring eTMF accuracy, completion and ongoing quality for all studies.
Supports GTL's review of study documents such as synopsis, protocol/protocol concept sheet, ICF, CRFs, CRF completion Guidelines, Study Execution plans, Clinical Data Review Plan, Clinical Database edit specification, Clinical Study Report (CSR). In situations where Principal GTA is the lead of a study the will perform these tasks.
Supports country and site feasibility/selection processes with use of robust data.
May support the development of the subject recruitment/retention strategy and related initiatives
Oversee/Supports study specific CSR appendices, as needed.
Supports GTL in providing input and communicating with the appropriate teams for response to country/regulatory IRB/IEC.
Assists with data, protocol deviation review, and study level trackers.
Participates in Audit Response Team, CAPA, and inspections.
May be responsible for managing certain company-sponsored study types from start-up through close-out (e.g., NPP, HEOR, with patients).
Reviews vendor invoices and lead approval process or submits to GTL's for approval (as needed); manages accruals and LSD/SOW changes.
Provides input to the development/management of the vendor scope of work/LSD per contract, quality, and budget under the supervision of the GTL and outsourcing manager
Reviews the study budget worksheet for completeness and accuracy
Participates in updating financial forecasting and support GTL with financial reconciliation activity
May support GTL in managing/overseeing vendors
Participates, sets up agendas, and captures meeting minutes in study team meetings for assigned protocols.
May support or lead study closure activities
Can operate in a highly independent fashion; proactive in trying to find solutions before flagging to direct reports
Helps GTL facilitate collaboration across teams, functions; looks for opportunities to lead meetings/discussions
Accomplishes operational tasks with overall project objectives in mind; shows foresight in flagging to GTL
Acts as a mentor for more junior Global Trial Associates (GTAs)
Flexible and can adapt to different GTL working styles
Develops and maintains effective working relationships with people across functions, therapeutic areas (TAs), cultures
Maintains optimism and composure in times of change, uncertainty, or stress and shows willingness to take on added responsibility during peak periods
Provides input into timely, data-driven decisions
Looks to build understanding of global considerations by participating in RDL-GTL and CTM-GTL discussions
Seeks opportunities to participate in strategy discussions; looks to get exposure to studies across phases, TAs, locations
Motivates team members
Has a high impact on study team and enables GTL
Uniquely Interesting Work, Life-changing Careers
R1604570 : Principal Global Trial Associate
Originally posted by RayzeBio. View original posting
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