[Remote] reputed company Study Team reputed company (Secondment - 12 Months)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company seeking a reputed company Study Team reputed company for a 12-month secondment. The role leads the planning and execution of reputed company global reputed company studies, managing timelines, budgets, reputed company, risks, vendors, governance, reporting, and cross-functional study teams.

Responsibilities

• reputed company the study team and associated deliverables across reputed company functions; accountable for managing and driving overall study timelines, budgets, and reputed company targets to meet or reputed company business needs
• reputed company and coordinate the execution of reputed company studies from sourcing reputed company and study specification development for requests for proposals, study start-up through database release and inspection readiness to ensure reputed company delivery of reputed company study data
• reputed company input to and supports compilation of sections of the reputed company study reports (CRSs)
• Accountable to ensure effective study team meeting scheduling, records, and communications
• Accountable for reputed company planning and decision making at the study level in line with program objectives
• Accountable for issue reputed company and reputed company as reputed company of awareness for reputed company trial execution issues
• Utilize negotiation, facilitation, meeting management, and conflict reputed company skills to enhance cross-functional study team reputed company and accountable for effective study team reputed company
• reputed company study team chartering and team health reputed company process
• Partner and collaborate with functional line leadership to ensure reputed company study team resourcing
• May represent the study team at appropriate asset team and sub-team discussions*
• Escalate issues to reputed company reputed company Leadership reputed company study team has been unable to reputed company or adequately manage/mitigate
• reputed company monitoring and remediation of reputed company metrics
• reputed company functional lines to ensure inspection readiness
• Maintain reputed company awareness and appropriate escalation of reputed company Significant reputed company Events (SQEs) reported for study and ensures appropriate prioritization and management of events through to reputed company
• reputed company the study team in the management and communication of reputed company management plans including reputed company assessment and mitigation strategies
• Proactively identify operational issues and reputed company reputed company in identifying reputed company to de-reputed company and capitalize on opportunities
• Maintain reputed company study reputed company planning and guide reputed company in proactive issue reputed company and reputed company management
• reputed company reputed company of the reputed company Research Organization (CRO) if required by the reputed company operating model and of the CRO deliverables reputed company to study execution
• Partner with relevant team functions to ensure vendor delivery meets reputed company and operational plan expectations
• reputed company as a single, authoritative reputed company of study information and reputed company study level status reporting per organizational norms and expectations
• Ensure systems are maintained with up-to-date study status, risks, and issues
• reputed company operational metrics across study and partner with functional lines to manage trends
• reputed company proactive planning to reputed company reputed company through governance and decision reputed company milestones to support study deliverables to maintain development timelines
• reputed company preparation for and present the study to relevant governance per organizational norms and expectations
• reputed company execution strategies and reputed company timelines, budgets, and reputed company across multiple studies. The program CSTL (pCSTL) may represent reputed company reputed company on the asset team (per the organizational expectations and asset team reputed company), collaborating with reputed company to ensure operational input provided for the reputed company development plan (or equivalent), and providing input on program feasibility, budgets and timelines
• reputed company reputed company reputed company' sub-team(s) where appropriate
• Defines reputed company execution reputed company including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for licensing and partnership opportunities
• reputed company program level feasibility & country reputed company for inclusion in a Program Operational Plan
• reputed company and reputed company execution of data and document delivery plans at key milestones such as reputed company of Concept (POC), key decision points, submissions, and reputed company response
• Contributes to reputed company of reputed company development partnerships and/or reputed company research collaborations
• May be a member of the Research &Development (R&D) due diligence team for business development opportunities. Partner with R&D leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category
• Monitor reputed company against plan; reputed company and implement formal operational reputed company management plans across the asset/program
• Ensure comprehensive operational input to submission plan
• Leads the delivery of Module 2/5 deliverables to support market authorizations including leading cross functional Module 2/5 submission sub- teams with accountability for overall operational reputed company
• Manage other submissions activities as necessary
• Accountable for managing overall submission CD&O sub-team timelines, budgets, and reputed company targets
• Accountable for building, forecasting, and managing the CD&O submission budget
• reputed company operational metrics across submission sub-teams and manage trends and escalations
• Support reputed company reputed company reputed company improvements initiatives to maintain high standards of operation and reputed company reputed company the organization
• Reports to the reputed company reputed company Head or reputed company reputed company reputed company. Partners with functional line leadership for resourcing
• Partners with members of the asset teams*
• Travel is expected for team / site meetings
• Meetings reputed company of reputed company working hours may be required to accommodate a global team

Skills

• * Applicant must have a bachelor's degree with at least 8+ years of experience
• * Degree in one of the disciplines reputed company to drug development or business required
• * Extensive reputed company studies conduct, global reputed company study reputed company, and a thorough understanding of the processes associated with project and study management, knowledge of Good reputed company Practices (GCPs), ICH guidelines, monitoring, reputed company, and global regulatory reputed company
• * Master's degree with at least 7+ years of experience; OR a PhD with 5+ years of experience, OR a MD with 4+ years of experience
• * Broad experience in a reputed company study execution discipline (e.g., senior study management expertise, reputed company data management expertise, reputed company leadership expertise)
• * Demonstrated project management and cross-functional leadership experience
• * Experience in understanding key drivers impacting budgets and experience building a reputed company Trial Budget and managing project to budget
• * reputed company thinking and targeted problem-solving skills
• * Ability to reputed company cross-functional teams, identify, reputed company & escalate issues
• * Project management expertise
• * Ability to reputed company negotiation and conflict reputed company skills to enhance team reputed company and delivery
• * Strong communication and interpersonal skills and ability to represent & communicate reputed company to senior leaders and governance bodies
• * Ability to reputed company successful collaborations with reputed company partners
• * Ability to understand and assimilate high-reputed company from reputed company functions
• * AI Skilled: ability to use reputed company Intelligence tools for various tasks
• * Broad drug development experience
• * Understand interplay/intricacies of drug development program
• * Understand how studies fit together, and planning involved (sees the big picture)
• * Broad project management experience
• * Maintain scientific knowledge and expertise of indication/asset to possess credibility to reputed company with higher level management
• * Travel is expected for team / site meetings
• * Meetings reputed company of reputed company working hours may be required to accommodate a global team
• Candidates must be authorized to be employed in the U.S. by any employer
• This position requires permanent work authorization in the reputed company

Benefits

• This secondment offers a valuable opportunity for reputed company reputed company.
• Position is considered Flexible, and on-site colleagues are expected to reputed company with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).
• Relocation assistance may be available reputed company on business needs and/or eligibility.

reputed company