Director, Site Activation & Study Start Up

Year    Hyderabad, Telangana - Secunderabad, Telangana, India

Job Description


Title: Director/Associate Director Location: Hyderabad (Hybrid, 5 days onsite in 2 weeks) This role has accountability over a team of Global Trial Acceleration Managers and Coordinators focusing on document package creation and support of vendor services which support all BMS Clinical Trials across the enterprise and engages closely with clinical trial vendors across multiple service categories of clinical trial activities in R&D. Key Responsibilities Leads a team of Global Trial Acceleration Managers and Specialists ; serves as main point of escalation for trial-level outsourcing concerns Ensures timely and high-quality provision of document and vendor services to all BMS clinical trials Oversees a team and process to ensure ongoing commitments are met across all BMS clinical trials; engages in continuous process improvement to accelerate trial launch and delivery. Determines and executes CTA package creation process while overseeing, approving, and developing a thorough understanding of global requirements Leads BMS\'s GTAC functions to embed industry-leading processes and principles that define how BMS interacts with and manages its CTA Package Creation and vendor launch across all BMS Clinical Trials Leads BMS\'s GTAC function to ensure that all trial and regulatory obligations, SOP\'s, business practices and guidelines are adhered to in the execution of BMS\'s GTAC function Collaborates within BMS\'s matrix structure to establish efficient and effective CTA package creation processes to ensure all critical clinical trial milestones are met Responsible for resource planning and management to ensure adequate resources are available to manage the book of work and proactive resource planning to ensure future resourcing is in line with forecasted business needs Setting goals and objectives for the GTAC function that are aligned with the business objectives of the organization and establishing appropriate metrics, KPIs and scorecards to measure achievement of those goals and objectives Researches & brings forward industry trends and innovation in the field of GTAC and where beneficial to the BMS organization, introducing these innovations within the GTAC group Partners with GRS, RCO, and other BMS functions to select ensure CTA package creation aligns with all local requirements Qualifications & Experience A minimum of a BA or BS Degree in a clinical or scientific discipline (advanced degree a plus) A minimum of 10+ years of relevant industry experience (pharma, biotech, CRO) required; scientific, financial, and business problem-solving experience desired Prior experience with ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma, Strong organizational, time-management, analytical and decision-making skills in order to efficiently evaluate, plan and accomplish work goals Track record of influencing key internal and external stakeholders (including senior leaders) to obtain buy-in to influence or implement change Demonstrated influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a team Direct experience working directly with Contract Service Providers (CSPs) across vendor categories, as well as broad exposure to clinical trial operations in general. This role requires clinical trial operational experience, strong stakeholder management skills, and the ability to work across a highly matrixed and global organization. Demonstrated ability to build alliances to gain key stakeholder support, buy-in and ownership and maintain trust Demonstrated ability to make sound decisions based on a balanced evaluation of available information within a complex environment of competing project priorities Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiples demands on role in a responsive and professional manner Direct people management experience with proven ability to engage teams and inspire them to sustain high levels of performance in a constantly changing environment

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Job Detail

  • Job Id
    JD3186567
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Hyderabad, Telangana - Secunderabad, Telangana, India
  • Education
    Not mentioned
  • Experience
    Year