Samira Lavingia
Bensalem,PA
Summary
Accomplished clinical research professional with 15+ years of experience in managing operational aspects of clinical trials from start-up to database lock in adherence to regulatory requirements, timelines, and budgets. Demonstrated ability to work independently and in a team environment. Strong skills and knowledge of clinical trial operations with experience in pharmaceutical and medical device studies. Excellent mentorship and training skills with a quality mindset for continuous improvement.
Overview
16
16
years of professional experience
Work History
Senior Clinical Research Manager
Integra LifeSciences
11.2022 - Current
- Represented clinical operations within a cross-functional team consisting of medical affairs, regulatory affairs, to develop a cross-functional team consisting of medical affairs, regulatory affairs, to develop a comprehensive IDE study protocol
- Monitor study progress and provide regular updates to senior management and stakeholders.
Clinical Research Manager
Integra LifeSciences
09.2018 - 11.2022
- Led and managed retrospective clinical studies from start to finish in 3 months ahead of schedule and within budget to support CE mark renewal
- Fostered strong collaboration and communication across cross-functional teams to ensure study success
- Developed and implemented standardized and best practices to enhance operational efficiency, reduce variability and improve data quality in clinical trials via departmental grass-roots efforts.
- Provided training and mentorship to new team members and rotational team members, ensuring smooth onboarding and knowledge transfer.
- Skilled at working independently and collaboratively in a team environment.
House Clinical Research Associate, Site Manager
Novo Nordisk
09.2013 - 09.2018
- On all assigned studies, 80% of sites were activated prior to First Patient First Visit
- Selected for participation in the co-monitoring program based on visibility and leadership in the department
- Subject Matter Expert (SME) for web-based study start up tracking system and for the Clinical Trial Report (CTR) QC process
- Selected to be a facilitator/presenter for the New Hire Experience orientation
- Led project team in creation of department wide document for inclusion into the site’s ITF (Site Contact Sheet)
- Successfully launched an Employee Resource Group (ERG) for the Asian Pacific population
- Selected to facilitate Start-up and Close-out Clubs compromised of IHCRAs and provide just in-time training based on current stage of the study
- Recipient of President’s Award 2016 for successful completion of SWITCH 2 trial
- Recipient of Diversity and Inclusion Award 2016 and 2017 for establishment and successful launch of Asian Pacific Employee Resource Group (NASPAC)
- Acted as the main point of contact for sites for all study related matters
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance
Clinical Research Associate, In House
PRA International
10.2011 - 09.2013
- Supported line of business management to identify activities and documents out of scope (based on agreement with sponsor organization)
- Continuously provided back up for Country Start Up Specialist by ensuring team was on track to meet study milestones during start up
- Successfully managed large regulatory document volume from Site Management Organizations (SMO).
- Involved in IRB management, site management, sponsor management, and vendor management
Clinical Trial Associate
ReSearch Pharmaceutical Services
11.2010 - 03.2011
- Led the team in the conversion of paper Trial Master File to electronic Trial Master File (eTMF).
- Responsible for document review of regulatory documents received from sites and field CRAs
- Reviewed, negotiated and approved site-specific and study-specific ICF language
Clinical Project Assistant
Sanofi-aventis
05.2010 - 11.2010
- Responsible for distribution of Letters of Intent, Confidentiality Disclosure Agreements, and feasibility questionnaires to sites for study selection
- Processed investigator and patient payments.
Start-up Assistant
Kendle International, Inc
06.2009 - 05.2010
- Supported the establishment of the Study Start up team via SOP drafting and job description drafting.
- Involved in managing integrated start-up timelines and budgets against planned strategy and coordinating activities to gain Regulatory and Ethics Committee approval for clinical studies globally
- Participated in proposal development and bid defense preparations
Project Assistant
07.2007 - 06.2009
- Acted as the primary liaison between sites, sponsor team, vendors, and project teams
- Responsible for the design of study tracking reports such as patient enrollment reports and graphs
- Completed in-house monitoring activities as appropriate, such as updating in-house site files, and reviewing visit reports and resolving queries
- Coordinated Investigator Meetings, Study Coordinator Meetings, and study-related conferences for company staff and study staff attendance.
Education
MBA - Pharmaceutical Management
Drexel University
Philadelphia, PA12.2012
Bachelor of Science - Biochemistry
Rutgers University
New Brunswick, NJ06.2007
Associate - Chemistry
Middlesex County College
Edison, NJ06.2005
Skills
- Protocol, ICF, and Database Development
- Standard Operating Procedure (SOP) Writing
- CRO and Vendor Management
- Budget and Timeline Management
- Study Planning and Management
- Cross Functional Collaboration
- Training and Mentoring
Languages
Urdu
Native or Bilingual
Timeline
Senior Clinical Research Manager
Integra LifeSciences
11.2022 - Current
Clinical Research Manager
Integra LifeSciences
09.2018 - 11.2022
House Clinical Research Associate, Site Manager
Novo Nordisk
09.2013 - 09.2018
Clinical Research Associate, In House
PRA International
10.2011 - 09.2013
Clinical Trial Associate
ReSearch Pharmaceutical Services
11.2010 - 03.2011
Clinical Project Assistant
Sanofi-aventis
05.2010 - 11.2010
Start-up Assistant
Kendle International, Inc
06.2009 - 05.2010
Project Assistant
07.2007 - 06.2009
MBA - Pharmaceutical Management
Drexel University
Bachelor of Science - Biochemistry
Rutgers University
Associate - Chemistry
Middlesex County College
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