Principal Global Trial Associate

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position SummaryProvides operational support for global insourced or outsourced, Non-Registrational Data Generating or Registrational Data Generating interventional clinical trials from concept to final clinical study report. May be responsible for a clinical trial(s) in the maintenance or close-out phases of its life cycle. May provide operational support to one or more cross-functional study team(s) and /or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors. Focuses on project management concepts to support management of issues, risks, timelines, and budget. Manages the development and/or collection of study level documentation and support Global Trial Lead (GTL) in ensuring eTMF accuracy and completion for all studies. Has high functional impact on the study team and the organization. Manages country planning, protocol level attributes and milestones/drivers in CTMS. Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned. Duties/Responsibilities Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to, the following: Project Management ResponsibilitiesSupports 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 Study Planning, Conduct & Closure Responsibilities 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 Leadership CompetenciesCan 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 Reporting Relationship This role will report into a line manager within Global Trial Management. The GTA can potentially support any therapeutic areas and research phase and will collaborate with cross-functional global teams to execute assigned operational aspects of global clinical research studies from protocol development to final clinical study report. Technical CompetenciesKnowledge of ICH/GCP, regulatory guidelines/directives, drug development, and clinical research processes Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint Management Competencies Demonstrated project management experience in the pharmaceutical or healthcare industry Ability to manage multiple deliverables and nimbly respond to changing business demands Adaptable and flexible—willing/able to adjust to multiple demands and shifting priorities and demonstrates ability to meet day-to-day challenges with confidence and professionalism Leverages interpersonal and influencing skills to foster partnerships across multidisciplinary teams Has adequate knowledge of the projects (both insourced and outsourced), and the ability to zoom in and out as the situation demands. Education/ExperienceBA/BS or equivalent degree in relevant discipline required Min. 4-6 years of clinical research/global study operations experience Moderate familiarity with global regulatory landscape/submission timelines No direct project management experience required Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems Travel requirement of up to 5% Based on your functi