Michelle Joseph
Medway,United States
Summary
Strong leader and problem-solver dedicated to streamlining Clinical Data Management operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success. Demonstrated strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Strategic-thinker experienced in turning low-performing departments into top revenue producers always looking to optimize processes, gain efficiencies and ensure high quality results.
Overview
18
18
years of professional experience
Work History
Director, Clinical Data Management
Alkermes Inc / Mural Oncology Inc
08.2023 - Current
- Responsible for oversight of Data Management department supporting all clinical development programs including CRO/EDC vendor selection and management, timelines, budgets, data metrics & reporting, and personnel management.
- Optimized operational processes using analytics tools to address study-specific metrics.
- Spearheaded revamp of data management process documentation after thorough evaluation of company documentation to verify alignment with regulatory requirements.
- Developed innovative approaches to resource allocation and strategic planning across studies.
- Collaborated closely with other functional departments like Clinical Pharmacology and Translational Medicine to improve external data handling process ensuring timely and high-quality deliverables from external vendors.
Associate Director, Clinical Data Management
Alkermes Inc / Mural Oncology Inc
01.2021 - 07.2023
- Supervisory and leadership responsibilities for all data management and back-end activities supporting Oncology program from DM strategy, database start-up through database archive.
- Pioneered implementation of Medidata Rave EDC at Alkermes.
- Assisted senior leadership in managing all aspects of data management operations for both Omnicomm and Medidata Rave EDC systems.
- Communicated all capacity, resourcing and technology gaps with upper management.
- Worked closely with management to implement change in operation model for complex oncology studies and successfully ensured database lock prior to company spin off.
- Tracked key data management metrics provided by CRO vendor and made recommendations for proactive adjustments to processes and procedures thus ensuring stability of oncology studies in data management.
Manager, Data Management
Veristat
01.2019 - 12.2020
- Completed EDC designer certifications in Medidata Rave® – 2019, and Medrio EDC.
- Onboarded and led team of data managers in Canada - Montreal and Toronto and Taiwan.
- Represent data management at all Sponsor audits.
- Provide strong leadership in management of Oncology studies in Medidata Rave in department.
- Responsible for creation of optimal workflow for EDC designs using multiple EDC platforms including development of data standards.
Senior Clinical Data Manager
Veristat
07.2015 - 12.2018
- Worked on mid to large sized complex projects specific to Oncology.
- Conducted Oncology specific training for junior hires including creation of training documents, Standard Operating Procedures and templates for department.
- Represented data management at bid defense meetings, response to RFPs, sponsor audits and well as Principal Investigator meetings.
- Involved as senior consulting for rescue studies, complex EDC design builds and submission deliverables involving data management.
Clinical Data Manager II
Veristat
05.2013 - 07.2015
- Managed 4-5 mid to large sized projects across various indications.
- Responsible for overseeing junior level data managers.
- Gained recognition for deep insight into Oncology specific EDC design and data management documentation.
Clinical Data Manager
Smith Hanley Consulting Group
03.2012 - 05.2013
- Experience in managing studies using Oracle Clinical (OC 4.5.1) EDC, InForm GTM 5.0 and ClinTrial – 4.3
- Lead data manager for small to mid-size projects from study start up to closeout.
- Collaborated with senior lead data managers for data cleaning of Oncology studies including SAE reconciliation, External data reconciliation and RECIST data cleaning.
Associate Clinical Data Manager
Smith Hanley Consulting Group
12.2011 - 03.2012
- First in department to successfully complete eClinical OS – 5.0.0 (now called Zelta) EDC designer certification.
- Created and updated Clinical database (EDC) designs for various Sponsors across a number of therapeutic areas.
- Wrote and maintained technical and functional specifications for the data management department.
Team Lead - Clinical Coding
Tata Consultancy Services
01.2008 - 01.2010
- Successful implementation of clinical coding process.
- Lead role in establishing strong core pilot team, dedicated towards compliance, monitoring, problem solving and superior quality coding deliverables.
- Minimized resource and time losses by addressing employee or production issue directly and implementing timely solutions.
Clinical Data Manager and Medical Coder
Cognizant Technology Solutions
01.2007 - 01.2008
- Implementation of clinical coding process for various sponsors.
- Successfully trained in end to end data management tasks from study start up to study closeout.
- Demonstrated creativity and resourcefulness through development of innovative solutions for data management.
Team Coordinator
Cognizant Technology Solutions
01.2006 - 01.2007
- Responsible for clinical coding process implementation.
- Developed solid process documentation to broaden efficiency of clinical coding department.
- Managed team workload to reach targets for all clinical coding assignments.
Education
Masters of Science - Biotechnology
University of Essex
United Kingdom09.2005
Masters of Science - Botany
University of Mumbai
India06.2004
Bachelor in Science - Botany and Biochemistry
St. Xavier's College
India06.2002
Skills
- Implementation of new processes and technology solutions
- Personnel management
- Revitalized strategies and goals
- Process optimization and automation
- Deep insight in external data handling
- Ability to adapt to changing study needs while ensuring business continuity
- Contract and Vendor Management
References
Available upon request.
Timeline
Director, Clinical Data Management
Alkermes Inc / Mural Oncology Inc
08.2023 - Current
Associate Director, Clinical Data Management
Alkermes Inc / Mural Oncology Inc
01.2021 - 07.2023
Manager, Data Management
Veristat
01.2019 - 12.2020
Senior Clinical Data Manager
Veristat
07.2015 - 12.2018
Clinical Data Manager II
Veristat
05.2013 - 07.2015
Clinical Data Manager
Smith Hanley Consulting Group
03.2012 - 05.2013
Associate Clinical Data Manager
Smith Hanley Consulting Group
12.2011 - 03.2012
Team Lead - Clinical Coding
Tata Consultancy Services
01.2008 - 01.2010
Clinical Data Manager and Medical Coder
Cognizant Technology Solutions
01.2007 - 01.2008
Team Coordinator
Cognizant Technology Solutions
01.2006 - 01.2007
Masters of Science - Biotechnology
University of Essex
Masters of Science - Botany
University of Mumbai
Bachelor in Science - Botany and Biochemistry
St. Xavier's College
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