Associate Director, Clinical Data Management

Associate Director, Clinical Data Management

BMS - Bristol-Myers Squibb

Warsaw, Poland

Position Summary

The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline.

Position Responsibilities

Program Management

• Act as a Program Lead to provide oversight of a program within the organization providing oversight to a group of studies and Data Management Leads ensuring that the studies within the program are delivered per corporate goals and objectives;
• Establish a governance framework for a program or asset to ensure monitoring of risks and mitigation strategies across different studies within the program;
• Developing strong and productive working relationships with cross functional stakeholders responsible to provide strategic support to project team;
• Responsible for attending program level strategic meetings;
• May act as a driver to set program level data collection and review standards with cross functional team in partnership with global standards.

Line Management

• Line management responsibility of Data Management Leads based on business requirements;
• Manages the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trials;
• Forecast’s future resource needs based on the book of work and initiatives; proposing solutions to meet potential resource constraints;
• Assigns resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completion;
• Works 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 coaches and mentors’ staff, seeking out training opportunities where needed, to develop the next generation leaders;
• Develops and promotes a workplace culture that values diversity of thought, promotes integrity, creates accountability, supports effective decision making, and provides opportunities to grow.

Project Management and Leadership

• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects;
• Provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects;
• Responsible for end-to-end clinical data management activities and may serves as a primary point of contact for internal and external study team members;
• Provides strong quality and project oversight over third party vendor responsible for data management deliverables;
• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway). Enforces data standard conventions and quality expectations for clinical data per defined processes;
• May author, review/revise DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization;
• Participate in Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness;
• Represents DM on cross-functional project teams, portfolio review meetings & Submission Teams;
• Lead or support the Health Authority inspections and audits.

FSP/CRO/Vendor Oversight

• May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA).

Continuous improvement initiatives

• Supports change management initiatives with broad impact as a lead or participant in initiatives, and/or authors (or participates in) functional SOPs/WP/GD;
• Utilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionality;
• May mentor new or existing team members, as applicable;
• Lead CAPA management activities and ensure timely closure of CAPA action items;
• Holds accountability to resolve complex issues and proactively develop solutions, within the function and across functions. Leveraging technical/functional expertise to develop solutions. Using clear communications and collaborative strategies to drive to resolution;
• Authors 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.

Key Requirements

Degree

• Bachelor’s Degree required with an advanced degree preferred.

Experience

• At least 7 years of relevant industry experience;
• Project management certification (e.g. PMP) is desirable;
• Experience in managing late phase studies and portfolio for Data Management is highly preferred.

Key Competency Requirements

• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors;
• Sound knowledge of Clinical Drug Development Process, regulatory and ICH guidelines (e.g. EMEA, FDA) and industry standard practices regarding data management;
• Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection;
• Strong project management; Exhibits expertise in metrics analysis and reporting methodologies;
• Excellent oral and written communication skills;
• Communicate effectively with senior management and cross-functional teams;
• Solid knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)];
• Solution oriented mindset and ability to drive change.