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 rich in diversity. 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. BMS Hyderabad is an integrated global hub where our work is focused on helping patients prevail over serious diseases by building sustainable and innovative solutions. This important science, technology, and innovation center will support a range of technology and drug development activities that will help us usher in the next wave of innovation. Functional Area Description GDM&CM is responsible for clinical trial data acquisition, data standards governance, data management, medical coding, data reporting and analytics, and centralized monitoring for trials across the BMS R&D portfolio. Position Summary / Objective The Associate Director, EDC Database Development is a leadership role which contributes directly to the BMS R&D pipeline. This is a people management role. This role reports into the Head of EDC Database Development and is a full-time, office-based position. Position Responsibilities All Associate Directors may be responsible for the following but may focus on specific responsibilities as required by business need: Efficiently planning, coordinating, and delivering complete and high quality clinical databases for assigned studies, programs, assets and associated stakeholder groups. Taking responsibility for more complex studies in the portfolio which may require additional expertise. Developing Therapeutic Area database development strategy and collaborating with other functions in regards to programming deliverables (e.g. database design, high level project timelines). Holding accountability to resolve complex issues, leveraging technical/functional expertise to proactively develop solutions. Using clear communications and collaborative strategies to drive to resolution and remove barriers to execution. Leading initiatives with broad, cross-functional impact (including strategic process and technology improvements), influencing direction and driving to completion. Authoring database development procedural documents (SOPs, work instructions, job aids) and coordinating reviews/approvals. Ensuring procedural documents are reflective of industry standards and regulatory requirements, include optimal processes and are regularly maintained. Developing and maintaining database development templates and tools which support the function. Developing and conducting training and/or mentoring team members on key activities and processes. Ensuring consistency and adherence to BMS standards within a therapeutic area and the department as a whole. Managing database development trackers, metrics, and key performance indicators to ensure timely delivery, appropriate visibility, and proactive identification/resolution of issues and trends. Representing the function for Health Authority inspections and internal audits. Ensuring preparations and follow-up actions are completed effectively. Leading CAPA management activities, including root cause analysis and development of appropriate actions to address the root cause. Ensuring timely closure of CAPA actions. Ensuring effective quality oversight of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing activities on behalf of BMS to ensure high quality and timely delivery of clinical databases. Developing strong and productive working relationships with key stakeholders throughout GDM&CM, GDO, and BMS to drive results and remove barriers to execution. Representing BMS in interactions with key external partners as part of any committee or industry group. In addition to the above responsibilities, the following People Management responsibilities apply: Managing the book of work - assigning resources, ensuring high quality and timely delivery by team members. Leading the resolution of issues regarding the book of work - proposing solutions, aligning with impacted stakeholders, and driving to resolution. Forecasting future resource needs based on the book of work and initiatives proposing solutions to meet potential resource constraints. Assigning resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completion. Working proactively with staff to understand individual strengths, opportunities, and career goals supporting development of plans that capitalize on strengths and address opportunities providing regular feedback to promote development. Effectively coaching and mentoring staff, seeking out training opportunities where needed, to develop the next generation leaders. Developing and promoting a workplace culture that values diversity of thought, promotes integrity, creates accountability, supports effective decision making, and provides opportunities to grow. Degree Requirements Experience Requirements Bachelors degree required with an advanced degree preferred At least 7 years of global clinical trial expertise with a focus on EDC database development. Successful track record of leading through influence, working across complex, global organizational matrices, and effectively managing staff (for People Managers). Key Competency Requirements Deep understanding of the drug development process. Proven expertise in EDC database development processes and technologies. Strong knowledge of industry leading EDC tools (e.g., Medidata Rave, Oracle/Inform, etc.) and well versed in industry trends and emerging technologies supporting data collection. Strong knowledge of GCP/ICH guidelines, industry standard practices and good programming practices. Significant experience with inspection readiness and CAPA development. Proven record of proactively resolving complex issues, making decisions with an enterprise mindset, and driving significant initiatives to completion. Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles. Strong stakeholder management and project management skills. Excellent oral and written communication skills. Demonstrated partnership across various collaborative and industry forums. Diverse and deep technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory, quality etc.). Influential leadership and communication capabilities with a proven ability to engage and develop colleagues. #HYDDD #HYDDD If you come across a role that intrigues you but doesn\'t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as \'Transforming patients\' lives through science \', every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [HIDDEN TEXT]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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