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Seeking a US Based Consultant – with experience in UK Data
Can be based anywhere but must work Central EU time, so candidate may need to adjust accordingly months
Pay – - / hr
Bill – / hr
Can be CC
Veramed have an exciting opportunity for a Data Management Project Manager to provide data management support to the data management department across a range of projects, sponsors and therapeutic areas. The role can be based in US.
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 and to ensure all endpoints are captured
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
Participate in internal sponsor audits and RFIs as needed
Project Management :
Serves as the main contact for the sponsor
Leads kick off meetings for data management
Awareness of study budget and proactive identification and preparation of scope changes
Ensure key project milestones are delivered on time with the highest quality
Maintain timelines and communicate risks to the study teams
Leads the team conference calls from a data management perspective, provides metrics updates and is responsible for the DM timelines
Collaborate with cross-functional team members to ensure that the study deliverables are provided on time and with quality
Provide external CRO oversight to sponsors as needed
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
Line management of team members as appropriate
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 years of data management experience.
Other Information / Additional Requirements
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