Opis stanowiska:
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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.
Stanowisko Summary
The Associate Director, Clinical Data Management is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline.
Stanowisko 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 objectivesEstablish a governance framework for a program or asset to ensure monitoring of risks and mitigation strategies across different studies within the programDeveloping strong and productive working relationships with cross functional stakeholders responsible to provide strategic support to project teamResponsible for attending program level strategic meetingsMay act as a driver to set program level data collection and review standards with cross functional team in partnership with global standardsLine Management
Line management responsibility of Data Management Leads based on business requirementsManages the resource assignments ensuring appropriate support is in place to provide data quality oversight for clinical trialsForecast’s future resource needs based on the book of work and initiatives; proposing solutions to meet potential resource constraintsAssigns resources to initiatives in line with their development plans and providing appropriate guidance to staff to influence results and drive to completionWorks 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 Następna 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 projectsProvides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projectsResponsible for end-to-end clinical data management activities and may serves as a primary point of contact for internal and external study team membersProvides strong quality and project oversight over third party vendor responsible for data management deliverablesTakes 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 processesMay 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 standardizationParticipate in Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completenessRepresents DM on cross-functional project teams, portfolio review meetings & Submission TeamsLead or support the Health Authority inspections and auditsFSP/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/GDUtilizes knowledge of data management processes to evaluate and recommend new technologies and systems for improved data management functionalityMay mentor new or existing team members, as applicableLead CAPA management activities and ensure timely closure of CAPA action itemsHolds 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 resolutionAuthors 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 preferredKey Competency Requirements
Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendorsSound knowledge of Clinical Drug Development Process, regulatory and ICH guidelines (e.g. EMEA, FDA) and industry standard practices regarding data managementStrong 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 collectionStrong project management; Exhibits expertise in metrics analysis and reporting methodologiesExcellent oral and written communication skillsCommunicate effectively with senior management and cross-functional teamsSolid 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
Szczegóły oferty:
- Firma: Bristol Myers Squibb
- Stanowisko: Associate Director, Clinical Data Management
- Miejsce pracy: Warsaw
- Kraj: PL
Jak złożyć aplikację:
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