Overview
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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.
Responsibilities
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 Qualifications
* BSc or MSc in numerical discipline (or relevant equivalent industry experience).
* At least 7 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
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
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