Sr. Clinical Data Manager
ProClinical is partnering with a leading management consulting firm to advertise a vacancy for a Senior Clinical Data Manager position. The organization, which prides itself on its leading presence as a global advisor of talent supply chain strategies and workforce solutions, is seeking for a driven and talented individual to join its Massachusetts-based office. This is an exciting opportunity to work for an international company and bolster a career in the clinical field.
- Supporting CRF design, review, and validation of clinical database.
- Performing all aspects of user acceptance testing associated with clinical study databases, including, but not limited to, reviewing test scripts, facilitating test script approvals, and executing test scenarios defined within the test scripts with minimal supervision.
- Supporting a number of moderate complexity/complex trials with minimal supervision.
- Creating data management plans and other data management documentation as needed.
- Monitoring progress and conducting their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines.
- Coordinating, facilitating, and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise, and other BSDM functions for their respective projects.
- Participating in ongoing data reviews throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project.
- Identifying and addressing issues that may impact the quality of the data, deliverables, or timelines.
- Handling non-CRF data, including lab data and image handling.
- Coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed.
- Coordinating Medical Affairs organization to facilitate data coding and safety reviews as needed.
- Contributing towards process improvements, data standards, efficiency, gaining initiatives within data management, and working with data management leaderships needed.
- Ensuring all clinical data management documentation is stored and archived in a timely and compliant manner.
- Knowing and following all laws and policies that apply to the job, and maintaining the highest levels of professionalism, ethics, and compliance at all times.
- Diligently participating in compliance program-related activities as denoted by the supervisor of our Chief Compliance Officer.
Skills and Requirements:
- A Bachelor's Degree, or equivalent, in the biological sciences, computer science, or similar related discipline.
- At least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.
- Experience of supporting trials with minimal supervision.
- Therapeutic area knowledge in at least one of orthopaedics, gynaecology, cardiovascular, or general surgery.
- Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.
- Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Samantha Reader at + 267 983 0134 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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