Position Summary:
The Director, CDA Strategy is a leadership role with responsibility for delivering the strategy, technology roadmap, and processes for acquiring data for our clinical trials, keeping the site and patient experience at the forefront, providing data in line with end-to-end data strategies, enabling analysis and reporting and promoting automation. This role reports to the Head of Clinical Data Acquisition within GDM and is a full-time, office-based position.
Position Responsibilities
- Defining and driving the strategy for collecting clinical trial data, including site based (EDC) data, external vendor data, eCOA data, and other device/digital data, integrating with end-to-end data strategies. Developing the technology roadmaps required to deliver the strategy, promote automation and embed AI.
- Defining the processes, technologies and data flows required to collect new data types and deliver data to end users and/or to make significant updates to existing data types, ensuring standardization and integration across end-to-end data flow.
- Developing key data collection components designed to optimize the site and patient experience while ensuring downstream data requirements for analysis and reporting are effectively met.
- Leading broad cross-functional initiatives to establish industry-leading data capture capabilities, e.g., EMR to EDC to source data directly from EMRs. This includes creating project charters, project plans, sponsorship communications, implementation plans and driving projects from start to finish.
- Developing senior leadership level communications to share strategies, make proposals, and update on strategic initiatives. This could include business cases.
- Making decisions, solving complex problems and delivering on accountabilities.
- Staying on top of industry evolution to simplify/enhance user experience, leverage automation/AI, deliver operational efficiencies, and make appropriate investments to stay ahead of technology/data trends.
- Leading the development and maintenance of procedural documents which are reflective of industry standards and regulatory requirements and include optimal processes.
- Developing strong and productive working relationships with key leaders throughout GDM, DQS, Drug Development and BMS with the ability to think strategically and effectively express his/her views to senior management.
- Developing strong and productive working relationships with key vendors in the clinical data acquisition space and proposing the right advancements with the right vendors.
- Representing BMS in interactions with key external partners as part of any committee or industry group relating to data collection.
Degree / Experience Requirement:
- Bachelors degree required with an advanced degree preferred.
- At least 10 years of relevant strategy, technology and process experience specifically within clinical data acquisition across modalities (ie, site-collected, external, eCOA and device/digital data) including data integration, automation and incorporation of AI.
- Successful track record of leading, influencing, driving strategy and making decisions.
Key Competency Requirements
- Expert understanding of clinical data acquisition strategy, processes, technologies and end to end data flows.
- Proven expertise in EDC (including Medidata Rave), external vendor data, eCOA, and digital/device data, including strategy, processes and tools.
- Demonstrated experience with leveraging automation and AI to enable processes.
- Demonstrated ability to deliver tangible impact by planning and executing strategic projects involving cross-functional stakeholders.
- Proven record of making decisions, resolving complex problems and driving significant initiatives to completion.
- Strong, clear oral and communication skills, including the ability to craft communications and business cases for senior leadership.
- Strong knowledge of GCP/ICH guidelines.
- Demonstrated partnership across various collaborative and industry forums.
- Diverse and sufficient technical expertise to be a credible interface to all global development and business partners across clinical data acquisition types.
- Broad intelligence of clinical data acquisition including future trends.
- Influential leadership and communication skills.
