Join Veramed as a Senior Clinical Data Manager in a full-time, hybrid or UK office-based role. You will lead data management study start-ups, EDC builds using Medidata Rave, and vendor management across various therapeutic areas, enjoying an industry-leading working environment with a B Corp accredited company.
Requirements
BSc or MSc in a numerical discipline, or relevant equivalent industry experience.
At least 7-8 years of relevant industry experience in clinical data management.
Strong and in-depth experience in Data Management Study Start-Up, Management of EDC Build, Medidata Rave (including eCOA), and vendor management.
Understanding of the clinical drug development process, disease areas, endpoints, study designs, industry/project standards, and ICH guidelines.
Excellent verbal and written communication, problem-solving, and project leadership skills.
Skills & Responsibilities
Medidata Rave & EDC: Manage EDC builds and UAT documentation to ensure clean, high-quality data ready for analysis.
Study Start-Up: Oversee new data management study start-ups, review clinical protocols, and create Case Report Forms and edit check specifications.
Vendor Management: Work with external vendors on data transfer agreements and ensure proper external data reconciliation.
Leadership & Mentorship: Lead study team meetings, communicate risks, and mentor more junior team members.
Potential transition routes: People from Clinical Research Associate or Clinical Data Coordinator roles may bring strong clinical trial and data review skills, alongside meeting the required industry experience.
Job description
An exciting opportunity to join Veramed's Data Management Business Unit! As we continue to grow and build on our success, we're looking to recruit a passionate and driven Senior Clinical Data Manager. You'll be required to have strong and in-depth experience of Data Management Study Start Up, Management of EDC Build, Medidata Rave (including eCOA) and experience of vendor management. Also This role can be based in our UK offices or a hybrid working model.
Veramed prides itself on two key areas: providing the highest quality Data Management, Statistics and Programming consultancy for its clients, and giving its employees an industry leading working environment with support and training for career growth.
Purpose:
The role of the Senior Clinical Data Manager is to provide data management support to the data management department across a range of projects, sponsors and therapeutic areas. Provide expertise and manage the start up of new data management studies.
Key Responsibilities:
The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
Technical:
Review of clinical protocols
Create or review Case Report Forms for data collection and compare with the protocol to ensure consistency
Create or review Edit Check Specification document
Preparation of UAT documentation and perform UAT of EDC and communication of findings
Creation of study specific documents such as Data Management Plan, Data Review Plan, eCRF Completion Guidelines, etc.
Create or review specifications for data review listings and / or customized reports to facilitate data cleaning
Ongoing review of data entered in EDC to ensure the data is clean for analysis
Issue queries to clinical monitors or investigational sites as appropriate
Resolve standard queries
Perform medical coding
Work with external vendors on data transfer agreements / specifications
Ensure external data is reconciled as required
Track queries and data cleaning activities to ensure ongoing review of data entered is completed and data is fit for analysis.
Maintain study master file documents and any other documents that are required to be audit ready
Work in accordance with internal (or sponsor, where applicable) SOPs and procedures
Project Management:
May serve as the main contact for the sponsor
Awareness of study budget and proactive identification of scope changes
Ensure key project milestones are delivered on time with the highest quality
Maintain timelines and communicate risks / updates to the Data Management Project Manager
Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality
General:
Lead internal and client study team meetings effectively
Present study updates internally and at sponsor meetings
Share scientific, technical and practical knowledge within the team and with colleagues
Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
Build effective collaborative working relationships with internal and sponsor team members
Seek opportunities to develop innovative ideas and sharing when appropriate
Mentorship of more junior team members
Contribution to development of internal training materials
Contribution to internal process improvement initiatives
Minimum Qualification Requirements
BSc or MSc in numerical discipline (or relevant equivalent industry experience).
At least 7-8 years of relevant industry experience.
Understanding of clinical drug development process, relevant disease areas, endpoints, and different study designs
Awareness of industry and project standards & ICH guidelines
Excellent verbal and written communication skills
Interpersonal/teamwork skills for effective interactions
Self-management skills with a focus on results for timely and accurate completion of competing deliverables
Demonstrated problem solving ability and attention to detail
Project leadership experience
Ability to make informed and appropriate decisions
Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.
As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.
