Associate Director, Clinical Data Management

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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 with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. 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 (include, but are not limited to) 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 #LI-Hybrid If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Warsaw - PL: zł325,830 - zł394,830 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordin