Associated Director, Clinical Data Management - Boudry, Schweiz - Bristol Myers Squibb

Bristol Myers Squibb

Geprüftes Unternehmen

Boudry, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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 rich in diversity.

Take your career farther than you thought possible.

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

This role may report into Director within the Clinical Data Management function. This is a 50% office-based position.

Responsibilities will 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 endtoend 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 ongoing review of trial data currency, quality and completeness
Represents DM on crossfunctional 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 endtoend 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