Sharon Jelleme
Metuchen,NJ
Summary
Senior Clinical operations professional with over 25 years in the pharmaceutical industry, currently managing a team of Clinical Research Associates (CRAs). Known for fostering team collaboration and adapting to evolving needs, consistently delivering high performing team results. Strong analytical skills, strategic thinking, and effective communication skills enable success in driving operational excellence.
Overview
28
28
years of professional experience
Work History
Senior Clinical Operations Manager
Bristol Myers Squibb
03.2022 - Current
- Provide leadership and guidance to monitoring group
- Manage a team of both full-time CRA employees and contract CRAs
- Supervises and coordinates the work assignments and performance of direct reports to ensure timely execution consistent with local research goals and company priorities
- Manages hiring and performance management of full time employees
- Supports Health Authority inspection and pre-inspection activities, including responding to and implementing CAPA action plans
- Tracks and manages performance metrics
- Recognized Subject Matter Expert for CTMS; developed several step-by-step documents to provide guidance for system and actively request updates to CTMS processes
- Therapeutic Area Lead; Associate director level role: Accountable for US monitoring TA deliverables across development structure, leadership of early development liaisons; point of escalation from other stakeholders
- Participates in SOP review and assist in updating and re-writing SOPs
Principal Clinical Research Associate
Celgene Corporation (now Bristol Myers Squibb)
04.2019 - 03.2022
- Manage and Monitor Investigative Site’s adherence to GCP, ICH guidelines and local regulations
- Supervise the conduct of clinical studies, ensure compliance with protocols, regulatory requirements and GCPs
- Build strong relationships with site personnel
- Conduct and document monitoring visits and CRO oversight visits
- Manage timely data entry and query resolution
- Conduct timely onsite and remote Source Document Verification and Source Data Review
- Review, maintain and reconcile central files with site file
- Oversee investigational product documentation, storage, accountability and reconciliation at the site
- Train site and Celgene personnel during internal and external meetings
- Maintain trial management systems
- Work effectively with other departments within the organization
- Participate in and conduct CRO oversight
- Mentor new CRAs
- Act as Lead CRA
- Train new CRAs during onboarding and on new processes
- Review and update SOPs, working procedures and Job Aids
Senior Clinical Research Associate
Celgene Corporation
11.2005 - 04.2019
- Conduct Pre-study, Study Initiation, Interim Monitoring and Close Out Visits at Investigative Sites
- Review investigator study files and reconcile versus trial master files
- Perform investigational product accountability
- Ensure timely submission and review of CRF data and query resolution according to timelines set forth in the Study Monitoring Plan
- Evaluate data query trends and interact with study team in order to improve data quality; ensure issues of data quality are escalated and resolved with study team and CQA
- Ensure investigative sites’ adherence to GCP, ICH guidelines, and local regulations
- Train Investigative Sites
- Identify site issues; ensure proper escalation
- Respond to audit findings
- Attend and participate in study team meetings
- Mentor new CRAs
- Identify/evaluate potential investigators for future Celgene studies
- Build effective and positive relationships with site staff
Regional Senior Clinical Research Associate
Covance, Inc
01.2004 - 11.2005
- Responsible for monitoring clinical trials within an assigned geographic region
- Maintain communication with project team members while working independently from a home office
- Conduct pre-study visits, initiation visits, interim visits, and close out visits
- Review trip reports
- Train and oversee new Clinical Research Associates and act as a mentor
Clinical Research Associate II
Covance, Inc
07.2002 - 01.2004
- Conduct pre-study visits, initiation visits, interim visits, and close out visits for Phase III studies
- Audit study files at sites for compliance with FDA regulations and company SOPs
- Prepare regulatory documents for IRB submission.
- Negotiate budgets and contracts
- Review and revise monitoring tools/guidelines
- Track regulatory documents
- Review trip reports
- Train in-house Clinical Research Associates and Regional Clinical Research Associates
- Lead and present at team meetings
Clinical Research Associate II
Bio-Technology General Corporation
07.1999 - 07.2002
- Assist in the development and management of multi-center clinical trials (Phase IV/Post-Marketing and Phase II)
- Prepare regulatory documents for IRB submission
- Conduct initiation, interim, and closeout visits
- Maintain and audit study files in-house and at sites for compliance with FDA regulations and company SOP’s
- Assist with reviewing protocols
- CRF design and development
- Train new Clinical Research Assistants
- Design monitoring/tracking documents
- Assist with monthly study status reports for Project Director and Manager
- Develop newsletters for sites
Senior Clinical Information Specialist
Schering-Plough Research Institute
03.1999 - 07.1999
- Supervise a team of Clinical Information Specialists and clerks
- Assign work, oversee daily adherence to procedures, and train new team members
- Responsible for processing documents, performing quality check on case report forms, conduct database searches, and generate database reports for clients
Clinical Information Specialist
Schering-Plough Research Institute
09.1997 - 03.1999
- Input specific information from regulatory documents
- Perform database audits for the Clinical Research, Medical Communications, Quality Assurance, and Clinical Data Management departments
Education
Bachelor of Science - Sports Biology
Springfield College
Springfield, MA05.1997
Skills
- Cross-Functional Relationship Building
- Excellent Communication and Interpersonal Skills
- Process Improvement
- Audit preparation
- Training and mentoring
- Onboarding and coaching
- Proficient in Veeva, iMedidata, OneNote, Microsoft Office, Communication tools (i,e, Teams, Zoom, Slack)
Timeline
Senior Clinical Operations Manager
Bristol Myers Squibb
03.2022 - Current
Principal Clinical Research Associate
Celgene Corporation (now Bristol Myers Squibb)
04.2019 - 03.2022
Senior Clinical Research Associate
Celgene Corporation
11.2005 - 04.2019
Regional Senior Clinical Research Associate
Covance, Inc
01.2004 - 11.2005
Clinical Research Associate II
Covance, Inc
07.2002 - 01.2004
Clinical Research Associate II
Bio-Technology General Corporation
07.1999 - 07.2002
Senior Clinical Information Specialist
Schering-Plough Research Institute
03.1999 - 07.1999
Clinical Information Specialist
Schering-Plough Research Institute
09.1997 - 03.1999
Bachelor of Science - Sports Biology
Springfield College
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