Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting
- About This Role: Veranex has an exciting opportunity to join our team as a Principal Clinical Data Manager. You will be part of a team working to improve lives globally through medical technology innovation. The Principal Clinical Data Manager will be responsible for oversee the day-to-day activities and task management of the project team to ensure a focus of quality, budget, and timelines on each project is reach and maintained. Manages data collection and quality control review of clinical data including external data. Develops project-specific data management plans that address areas such as data coding, reporting, database locks, workflow processes, etc. Establishes and maintains policies and procedures for gathering, analyzing, and reporting clinical data. Evaluates processes and technologies and suggests revisions to increase productivity and efficiency. Develops and implements strategies to improve the quality of data collected. Ensures data management services are delivered in a consistent, high-quality, timely and profitable manner
- What You Will Do:
- Develops the data management plan and other supporting study specific documents.
- Tracks and manages the overall project budget throughout the life cycle of the project.
- Initiates and leads improvements and assists in the development of the data management process.
- Liaises with stakeholders to investigate and provide solutions to issues with internal and external data/databases.
- Identifies operational and/or financial risks.
- Serves as primary escalation point for internal and external team members for risks associated with project.
- Actively participates in internal and client project team meetings.
- Manages resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
- Provides leadership, training, guidance, and support to data management staff.
- Participates in business development activities by serving as the primary data management representative during the business development process.
- Participates in audits and inspections as required for assigned projects
- Qualifications: Required skills:
- Bachelor’s degree or international equivalent in life science or computer science.
- 12+ years of relevant work experience
- A seasoned professional with full understanding of area of specialization. Resolves a wide range of issues in creative ways. Fully qualified level of the role.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Exercises judgment in selecting methods and techniques for obtaining solutions.
- Networks with senior internal and external personnel in area of expertise
- Preferred:
- In-depth knowledge of clinical research and the drug development process
- In-depth knowledge of clinical databases and query management
- Excellent written and oral communication skills
- Strong project management skills
- Excellent attention to detail
- Ability to solve complex problems
- Advanced ability to perform and lead all study initiation activities, clinical data cleaning, query management, validation, vendor reconciliation, study close-out activities, etc. on assigned projects.
- Advanced ability to effectively manage multiple tasks and projects
- Ability to lead and coordinate small teams
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
