Provide Data Management leadership for all aspects of Phase I Studies in data management to include but not limited to development of the project documentation, system set-up, data entry and data validation procedures and processes assigned to more junior staff. Also assume responsibility for all data management activities leading to database lock according to Client quality expectations, within project timelines and budgets.
Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.
Remote based is an option.
• 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).
• knowledge of drug development process
• knowledge of effective clinical data management practices
• fluent in english, both written and verbal
• in lieu of above requirement, approximately four years' experience in related field (e.g. pharmaceutical, laboratory, data analysis).
• knowledge of covance and the overall structure of the organization
• knowledge of covance standard operating procedures experience minimum required:
• early or late stage data management experience with direct sponsor management and one year technical mentoring experience.
• proven experience of handling customer negotiations and exposure to managing scope of work and budgets.
• knowledge of clinical trial process, dm, clinical operations, biometrics, and system applications to support operations.
• proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions.
• working knowledge of the relationship and regulatory obligation of the cro industry with pharmaceutical/biotechnological companies.
• time management skill and ability to adhere to project productivity metrics and timelines
• ability to work in a team environment and collaborate with peers
• good organizational ability, communication and interpersonal skills
• team working skills and good collaborator skills
• constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events.
• knowledge of medical terminology
• knowledge of science or a scientific background is preferred.
• good oral and written communication skills
• through knowledge of covance, the overall structure of the organization and standard operating procedures (sops).
• electronic data capture experience. eeo employer covance is committed to diversity in the workplace and is an equal opportunity employer. your confidentiality and privacy are important to us.