Associate Director, Clinical Data Management (Line Manager)

Summary

Providing leadership of clinical data management activities across multiple clinical development programs, overseeing a team of clinical data management professionals in planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.

Effective coaching and mentoring of Data Management Leads (DMLs) and other clinical data management staff in the team to ensure consistently high levels of performance and productivity in support of various clinical trial teams.

Strong coordination of activities across clinical data management, clinical data acquisition and standards, clinical data reporting and analytics, centralized monitoring, and medical coding to ensure cohesive support to clinical trial data collection, review, and reporting.

Roles and Responsibilities

Assignment of staff, providing support and guidance as needed, and working with peers to ensure consistent approaches in-

Gathering of data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.), including ensuring adherence to defined standards.

User acceptance testing to ensure high quality deliverables and inspection readiness at all times.

Implementation of the Data Quality Management Plan (DQMP) defining and documenting the data quality review strategy for each clinical trial in collaboration with various BMS stakeholders (e.g. statistics, medical, safety, development, GCO, etc.), enabling the quality review of patient data supporting regulatory filings, publications and other high-profile business activities.

Supporting clinical study report creation with input to the data quality assurance section as well as provisioning of sample and completed eCRFs/ePROs/eCOAs.

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

Contributing to the development and application of smart systems and optimal approaches to support the collection, integration, monitoring, review, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.

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, ad-hoc analysis and end-to-end data standards.

Leading a multi-national team of clinical data management 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 management.

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 7 years of relevant industry experience, with experience of managing staff in a global setting. Project management certification (e.g. PMP) is desirable.

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.

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

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

Experience in data management and well versed in industry trends and emerging industry dynamics concerning data review.

A good 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.