Job Overview :
Lead Project Data Manager, FSP
Remote from anywhere in the U.S. or Canada
Get ahead in your career and make a difference in people's lives!
Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.
If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.
The Lead PDM leads and / or supports the execution of data management activities necessary for the generation of hypothesis and for decision making in research or development phases, and for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community.
May assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s / he serves as the primary contact for Data Management on the Core Study Team.
As an SDM, the Senior Clinical Data Manager leads the DM team, which is comprised of several extended study team members, to ensure data management deliverables meet, or exceed, corporate and industry quality standards in a timely and cost efficient manner.
This includes the co-accountability with the Statistics Lead to create, maintain and manage the Project Plan. May also support research-driven activities, or support the handling of data provided by highly specialized functions (e.
g., Pharmacokinetic data, Biomarker data) ensuring data management best practices, and the usability of the generated data in regulatory processes.
The Lead PDM may also assume the role of a key driver of medical standards implementation and maintenance at the project level as well as ensuring a consistent standards handling in the project's studies.
This critical responsibility is necessary to ensure the project data is aligned with the Clinical Development Plan. Ensures consistency across studies through close interaction with the Clinical Project Team or Early Clinical Team, mentoring / coaching of SDM(s) and overseeing the Data Management team.
Contributions include, but are not limited to : vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.
g., QSD initiatives), presenting best practices at internal and external industry meetings meetings / congresses, and participating in due diligence assessments.
The Lead PDM is responsible for the consistency in support, planning and delivery of data management deliverables in assigned studies, projects (if applicable), or research activities.
S / he is contributing to the development and sharing of best DM practices. These efforts cascade throughout the supported research and drug development value chain.
to ensure proper governance of data management study set-up, conduct and closure activities.
Engages actively in ongoing data review / reconciliation activities and utilizes dashboards, metrics and patient trackers to
monitor data arrival and clean up. Shares data arrival and cleanup status and metrics with the Study Team
This includes but is not limited to the following : support of setting data standards compatible with development standards, support of central storage and inventory, supporting data transfer activities from external vendors, supporting integration with data generated in clinical phases of development.
OPERATIONAL DATA MANAGEMENT
identifies issues, defines and directs resolution measures; reports progress and escalate issues into management.
manages conflicts constructively; provides timely and relevant feedback.
Thrive personally and professionally as a Lead Project Data Manager
Working at Covance, you can bring your skills to the team and expect comprehensive training so that you can continue to grow in your career.
You will serve as the technical leader on all projects and identify and implement solutions for our clients in data management.
We also offer a competitive benefits package that takes care of you. This includes medical and dental insurance as well as tuition reimbursement, a 401(k) plan with a generous company match, PTO days along with short and long-term disability and life insurance.
Why choose to work at Covance
What we're looking for
Lead Data Managers are the most successful at Covance with :
Get to know Covance
At Covance, we value your unique point of view and bold ideas to advance modern healthcare. Join our team and see how our collaborative work environment along with mentoring, training and career development can help you be successful at work and in your personal life.
Together, let's shape new possibilities for your career and advance healthcare around the world.
Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Education / Qualifications :
Experience : pending