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Job Overview:Lead Project Data Manager, FSPpermanent, salariedRemote from anywhere in the U.S. or CanadaGet 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. In this role, you will: Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities and develop Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical Coordinate the development and testing of data management systems edit I data validation checks) diagnostics) and special listingsIprocedures used as tools for the data review and discrepancy management activities. Review data acquisition conventions and data review guidelinesIdiagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.Additional responsibilities include: Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and + Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications I monitoring conventions, Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality. Advanced planning and risk management for projects (issue escalation, resource management). Assist with goal creation and performance review assessment for data review project staff. Ensure project staff are trained and adhere to project-specific, global, standardized data management processes. Support achievement of project revenue and operating margin for data management activities to agreed target Identify areas for process and efficiency improvement and implement solutions on assigned projects. Maintain technical data management competencies via pa1ticipation in internal and external training seminars. Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget. Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities. Perform other duties as assigned by management. Review literature and research technologies/procedures for improving global data management practices.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 Make a direct impact in the lives of patients Become successful in the position with exceptional training Join a high-energy and team-driven workplace Open up new opportunities for career growthWhat we’re looking for Lead Data Managers are the most successful at Covance with: 6+ years of Clinical Data Management experience and at least 1 year of leading studies in a CRO setting. Combination of CRO/Pharma is acceptable. Bachelor’s degree; additional relevant work experience considered in lieu of degree. Full Experience including study start up, initiation, close out etc. Demonstrated skill for technical management of studies with 5+ staff. Experience with Database Build; eCRF creation; UAT experience. Demonstrated mentoring/delegation, communication and interpersonal skillsGet to know CovanceAt 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:
University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
Additional relevant work experience will be considered in lieu of formal qualifications.
Broad knowledge of drug development processes.
Understanding of global clinical development budgets and relationship to productivity targets.
Knowledge of effective clinical data management practices.
Knowledge of time and cost estimate development and pricing strategies.
Thorough knowledge of TCH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.
Experience:Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
Demonstrated skill for technical management of staff exceeding 5 employees.
Financial management of gross revenues in excess of $250K.
Excellent oral and written communication and presentation skills.
In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical Biotechnological.
Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
Demonstrated managerial and interpersonal skills.
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.
