Bristol-Myers Squibb Company

Director, Clinical Data Acquisition and Standards

Location
Princeton, NJ, US
Posted
Jun 03, 2018
Ref
R1506202
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

The Director, Clinical Data Acquisition and Standards is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Executive Director, Global Data Management and Centralized Monitoring within Global Clinical Operations (GCO)

Specifically, the Director, Clinical Data Acquisition and Standards is accountable for:

Providing operational leadership of the clinical data acquisition and standards function enabling the collection, integration, and aggregation of all clinical trial data from investigational sites and external vendors in accordance with industry standards and health authority expectations.

Development and timely delivery of electronic Case Report Forms (eCRFs) for collection of clinical trial data from investigational sites that are designed in accordance with documented specifications, as well as industry and BMS standards. Additionally, the programming of edit checks and custom functions that support real-time identification of data entry errors and inconsistencies.

Establishing and maintaining documented secure methods for data transfer from external vendors (e.g. eCRF vendor, central/specialized labs, ePRO vendors, IRT vendors, etc.) and ensuring a standardized approach is defined with preferred vendors.

Integration and aggregation of clinical trial data from multiple sources to facilitate ease of data review, reporting, and analysis.

Governance of the BMS data standards management framework that is aligned with industry standards (e.g. CDISC) and supports regulatory filings, publications and other high-profile business activities. Partnership with key stakeholders (e.g. statistics, medical, development, regulatory, GCO, etc.) to promote efficiency in data collection, review, and analysis via end-to-end data standardization.

Partnership with statistics in the development, testing, and implementation of Study Data Tabulation Model (SDTM) datasets for statistical analysis purposes.

Providing technical support to the maintenance of BMS medical coding dictionaries and synonym lists in partnership with the medical coding function.

Providing blank and completed eCRFs for investigational site archival, clinical study report, and regulatory submission purposes.

Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing clinical data acquisition services on behalf of BMS.

Understanding industry evolution to provide insight in the development and application of smart systems and optimal approaches that support the collection and integration of data which simplify and enhance user experience and/or lead to efficiencies in execution. Key expert contributor to establishing the next generation of clinical trial data collection at BMS (e.g. eSource, remote clinical trials, mHealth, wearables, metadata repository, clinical data repository, etc.).

Focusing on continuous improvement, defining and implementing the changes required to create an industry-leading clinical data capability, including electronic data capture, external data integration, and end-to-end data standards

Leading a multi-national team of clinical trial, data, and technology professionals that contribute significantly to BMS portfolio of clinical trials. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowers and holds staff to high quality performance and delivery of the business.

Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to data standards and technology.

Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

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 and promoting a work place culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability.

Experience and expertise required:

Bachelor's degree required with an advanced degree preferred. At least 8 years of relevant industry experience, with experience of managing staff in a global setting.

Significant global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Expert knowledge of industry leading eCRF tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.

A very good understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Strong technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

Previous leadership within data standards management and developing effective governance of data standards.

A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)

Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.

Influential leadership and communication capabilities with a proven ability to engage, manage, develop, and inspire a geographically diverse team.