Clinical Data Management Consultant
ProClinical is advertising a vacancy for a Clinical Data Management Consultant with a leading biotechnology company. The organization develops messenger RNA (mRNA) therapeutics and vaccines that have preventive benefits for both patients and healthy individuals. Based in the company's Massachusetts office, this position offers an exciting opportunity to work with a dynamic and innovative company that address currently undruggable targets and underrepresented areas of medical needs.
- Enabling the achievement of major data management deliverables and data milestones for oncology and rare disease programs in coordination with other functions including Medical, Clinical Operations, Pharmacovigilance, Biostatistics, and Statistical Programming.
- Taking responsibility for the quality of the data in each clinical database, as well as quality of other data management deliverables.
- Consulting with CROs to solve operational data issues.
- Working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools.
- Managing clinical trial data through review, cleaning, auditing, and validation procedures; ensuring data handling compliance with regulatory requirements.
- Ensuring the timing and integrity of data transfers from all vendors.
- Reviewing data analysis listings and report on performance and quality.
- Reviewing clinical data within studies and across for trend analysis.
- Supporting the strategy for data cleaning to ensure timely deliverables.
- Supporting the data collection through efficient eCRF and database design; ensuring thorough UAT requirements for database and test according to UAT Plan.
- Ensuring documentation and archival of data management deliverables.
- Maximizing intra- and inter-project standardization and sharing of best practices.
- Serving as a member of Clinical Study Teams and acting as the primary Data Management contact and contributor for assigned projects.
- Reviewing and providing feedback on protocols, Statistical Analysis Plans, etc.
Skills and Requirements:
- At least 10 years of clinical data management experience in industry, with experience with Medidata Rave® and experience with JReview® reporting software
- Early and late development experience; experience with oncology indications is a must.
- Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc.
- Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance.
- Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- 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 Mary Jacobs at +267-477-4800 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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