Director, EDC Database Development

Position Summary The Director, EDC Database Development (EDC DBD) is a leadership role providing strategic and operational leadership of the function that enables the acquisition of site provided clinical trial data to allow timely availability for review and analysis. This role reports to the Head of Clinical Data Acquisition and is a full-time office-based position with flexibility to work remotely up to 50% of the time. Position Responsibilities Providing comprehensive leadership for the EDC DBD function, ensuring the technology and processes are optimized and in line with industry standards and regulatory requirements. Setting the strategic direction of site based data collection and executing the strategy to effectively prepare for the future. Defining and implementing innovative solutions to advance, expand and further automate the effective acquisition of site provided data. Reducing site burden and accelerating EDC development timelines through these solutions. Ensuring quality development and timely delivery by the team of clinical study databases, meeting or exceeding study start up requirements. Holding accountability for all aspects of development. Ensuring optimized, effective, and compliant working procedures are defined and regularly maintained with the goals of streamlining and innovating. Providing leadership for the definition of key functional performance metrics, regular analysis of cross study deliverable trends and development of action plans to continually improve. Summarizing and sharing with stakeholders and leaders. Guiding the resolution of complex issues related to the function and those that cross functions. Directing team members to drive to resolution and keeping leadership informed of progress/results. Breaking down barriers to execution and working with an enterprise mindset to make decisions in support of company objectives and values. Leading significant cross-functional initiatives related to building an industry-leading site based data capture capability. Providing confident leadership for Health Authority inspections and internal audits. Ensuring preparations and follow-up actions are being completed effectively by the team, including CAPA development and root cause analysis. Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability. Leading a sizeable team of professionals. Providing ongoing feedback, coaching, and opportunities for career development. Focusing on engagement and retention of staff in order to maximize their potential. Empowering and holding staff accountable to high quality performance. Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities. Developing strong and productive working relationships with key stakeholders throughout BMS, demonstrating the ability to think strategically across R&D and effectively influence peers and leaders. Setting the strategy for effective use and quality oversight for external partners (e.g. Function Service Providers, CROs, outsourcing partners, etc.) performing activities on behalf of BMS. Representing the company with key external organizations as part of any committee or industry group relating to electronic data capture. Degree Requirements Bachelors degree required with an advanced degree preferred Experience Requirements At least 10 years of relevant industry experience, with substantial experience in setting and implementing strategy and managing delivery of portfolio facing deliverables. Key Competency Requirements Expert understanding of the drug development process, clinical trial execution, and site data collection/EDC processes and systems. Expert knowledge of industry trends and emerging technologies for site data collection/EDC. Expert knowledge of GCP/ICH guidelines. Expert understanding of system development lifecycle practices. Substantial experience leading a function and sizeable team. Proven record of operational delivery, resolution of complex issues and driving of significant initiatives to completion. Expert ability to lead and make decisions with an enterprise mindset, considering what is best for the company and for patients. Diverse technical expertise to be a credible interface to all global development and business partners (clinical, operations, commercial, regulatory, quality, etc.) Broad intelligence of the clinical trial environment across key regions and anticipation of future trends and impact. Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop, and inspire a geographically diverse team. Demonstrated partnership across various collaborative and industry forums.

Location: hyderabad, IN

Posted Date: 1/30/2025