ASSISTANT RESEARCH PROFESSORThe Biostatistics Center (Center) of the George Washington Milken Institute School of Public Health (GWSPH) is recruiting a 12-month Assistant Research Professor of Biostatistics and Bioinformatics to serve as Co-Investigator on an existing grant studying diabetes or other conditions. As a member of the Department of Biostatistics and Bioinformatics (DBB) faculty, the candidate will participate in Milken Institute School of Public Health faculty activities as well as educational activities at the graduate level. Salary is competitive and will be commensurate with experience and qualifications. GW has a strong commitment to achieving diversity among faculty and staff, and accordingly we encourage applications from members of underrepresented populations. Position will begin in Fall 2022. Applicants must either have a Doctorate in Statistics, Biostatistics, Bioinformatics, Epidemiology or Medicine, or have completed all of the requirements for the degree other than completion of dissertation, and have excellent oral and written communication skills, and pre- or post-doctoral collaborative medical research experience and publications as a co-investigator. Applicants pending completion of the dissertation will be considered for a conditional specialized faculty appointment at the rank of Research Instructor and must have their doctoral degree conferred by within 6 months of the start date of the position. To be considered, please complete an online faculty application at https://www.gwu.jobs/postings/93844. Only complete applications will be considered. Review of applications began on 7.21.2022 and is ongoing until the position is filled.
The George Washington University Biostatistics Center
Contact: Jessica Castillo
6110 Executive Blvd., Suite 750
Rockville, Maryland 20852 United States
Clinical Data ManagerLocation: San Francisco Bay Area or Vancouver, BC, Canada (Preferred) Status: Full time About Us: Platform Life Sciences is a rapidly growing global health contract research organization (CRO) specializing in conducting international platform clinical trials for medical interventions. We are headquartered in Vancouver, BC with satellite offices in Brazil, Pakistan, Rwanda, and South Africa. Platform Life Sciences is currently running the world’s largest placebo controlled COVID-19 trial, and we are expanding to other disease areas. Our founders and scientific leaders are serial entrepreneurs and professors at established universities. Role Summary: We are seeking a Clinical Data Manager responsible for the full life cycle of the electronic data capture (EDC) systems including integration, configuration, programming, operations, validation, and maintenance of the systems. You will serve as PLS’s main database infrastructure expert and will ensure the integrity of our clinical trials by monitoring the design, implementation, and maintenance of the electronic database. This role requires strong IT and EDC programming skills for the collection, management, analysis, and translation of data for multiple systems. The successful candidate will also need to develop thorough and resilient processes as well as robust, high-quality EDC and study forms to enable efficient and standardized study implementation at each of our trial sites. Reporting to the COO, your key responsibilities will be to: • Take ownership of end-to-end data management activities, including design, build, validate, launch, daily operation, and close out of clinical trial databases. • Develop organizational data management standards using internationally accepted standards (SCDM / CDISC / CDASH / STDM) • Develop and maintain Data Management Plan, guidance material, document deviations, log and report issues, and follow-up on their resolutions. • Provide input to strategic decisions for continuous quality improvement of data management within the organization. • Establish performance standards and KPI for EDC and eTMF systems. • Develop strategies to implement database upgrades and case report forms modifications to existing database structures in compliance with regulatory requirements and good clinical practice guidelines. • Establish and implement regular review process across study databases, to build and promote consistency and application of best practices and standards • Collaborate on defining requirements for collection forms for new and ongoing study protocols to ensure required data is collected on eCRF. • Collaborate on performing and organizing all aspects of the clinical database build and cross-functional User Acceptance Testing (UAT). • Collaborate on performing and organizing all aspects of Change Management to the EDC system. Ensuring timely and satisfactory implementation of mid-study changes. • Collaborate on developing and establishing procedures for gathering and reporting clinical data. • Develop forms and procedures required for the collection and compilation of data. • Develop test cases and test system upgrades and enhancements. • Devise and implement administrative procedures for the collection of data. • Design database specifications and modify existing software packages to meet specific research project needs. Education: • Masters degree in a relevant field Experience: • Experience as programmer and/or administrator of mainstream EDC (e.g. Medidata and/or Veeva) • Demonstrated an in-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards. • Minimum of five (5) years of relevant data management experience with clinical trial data management. • Strong knowledge of data privacy regulations • Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects. • Proven track record in integrating, implementing, and providing successful clinical data management. • Good knowledge and hands-on experience in difference aspects of IT systems (cloud, on prem, storage, back-up, etc.) • Demonstrated self-starter with a high level of commitment and the ability to influence others and resolve dynamic tensions. • Proven track record for making sound decisions. • Demonstrated skills in continuous improvement, project management, change management, and risk management. • Flexible to an ever-changing environment. Please apply with cover letter and CV.
Platform Life Sciences
Contact: Christina Guo
1505 W 2nd Ave
Vancouver, British Columbia V6H3Y4 Canada