Responsibilities:
This involves 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
Directs and delegates to assigned Global Trial Management staff as applicable.
Drives study execution utilizing available performance metrics and quality indicators (e. g. CTMS, eTMF reports, RBM reports), and study milestones and drivers.
Develops, manages, and maintains study deliverables (i. e. timelines, study plans, etc. ) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions
Proactively identifies potential risks, develops/implements actions, and makes the appropriate trade- offs of balancing risks with study deliverables and costs.
Maintains and updates data as appropriate in project management tools including CTMS.
Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans and recruitment status and raises potential issues/mitigation.
Requires minimal oversight to lead/manage projects.
Identifies, participates and/or leads initiatives with cross- functional/global teams.
Leads Study Team meetings, defines the agenda, captures meeting minutes, and facilitates cross- functional discussions.
Creates, maintains, and implements project management tools at the study level (e. g. actions, decisions, issues log and risk management plan).
Study Planning and Conduct Insourced Studies
Provides input to data, protocol deviation review, and patient tracker.
Provides strategic input into Study Team e. g. , on study documents.
Collaborates with CSO on global investigational product [IP] supply forecasting/management.
Participates in the subject recruitment/retention strategy and related initiatives (e. g. recruitment material).
Participates in clinical service provider (vendor) selection, specification development, and management / oversight.
Oversees TMF set- up, ongoing quality review, and operational oversight memo and requests final reconciliation.
Oversees eCOA activities throughout the lifecycle of the study.
Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.
Oversee study specific CSR appendices. Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.
Promptly shares information with key internal/external stakeholders at regular meetings.
Proactively identifies and anticipates issues and risks and oversees the creation of mitigation plans and implements resolutions.
Oversees service providers with minimal supervision.
Leads Audit Response Team and CAPA and participates in inspections. Supports the development/management/review of the vendor scope of work (SOW), invoices, accruals as per the contract, quality requirements, and budget.
Study Planning and Conduct Outsourced Studies
Reviews/approves functional plans (e. g. SAE management plan, PSV waivers, BMS confidentiality agreement for sites with master agreements with BMS).
Provides information to the CRO and reviews CRO deliverables.
Sets up and maintains Protocol Level training curriculum in SuccessFactors.
Reviews Protocol Level training for IM and SIV.
Owns overall and end- to- end study project management responsibilities.
Provides oversight and reviews all outsourced activities (protocol to CSR) in Clinical Pharmacology (NHV) studies.
Relationship Management
Proactively develops/maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.
Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable.
Ensures appropriate methods are used when communicating with key stakeholders and cross functional partners.
Leadership Competencies
Creates realistic plans that clearly define goals, milestones, responsibilities, and results.
Maintains focus on strategic objectives while accomplishing operational goals.
Places a priority on getting results with an emphasis on high quality outcomes. Holds self and others accountable for accomplishing goals.
Makes timely, data- driven decisions while balancing against daily priorities.
Develops and maintains effective working relationships with people across cultures.
Incorporates global considerations in everyday decision- making.
Encourages collaboration across teams, functions, and geographies.
Ensures that conflict is handled constructively so that performance is not impacted.
Displays a willingness to challenge the status quo and take risks.
Responds resourcefully to changing business demands and opportunities, proactively looking for ways the team can contribute.
Maintains optimism and composure in times of change, uncertainty, or stress. Executes to deliver on corporate objectives.
Acts as a mentor for the Study Team and function.
Supports development of GDO best practices.
Actively manages team behavior by mediating internal disputes, promoting energy/commitment, and recognizing and rewarding accomplishments.
Seeks opportunities for continued learning as to how strategy is shaped in the organization
