Associate Director, Clinical Data Management
Bristol Myers SquibbWünnewil
Publication date:13 June 2022
Associate Director, Clinical Data Management
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Responsibilities will include, but are not limited to:
- 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 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
- 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to Write an email. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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Bristol Myers Squibb