Carla Marchini Silva
Sr. Manager, Study Start Up PM, Clinical Trial Accelerator Unit at Biogen
- Role
- Sr Manager, Study Start up Pm at Biogen
- Location
- Woburn, MA, US
- LinkedIn followers
- 500 followers
About Carla Marchini Silva
Experienced professional with 19+ years of pharmaceutical industry/CRO experience in R&D global clinical operations, with skills ranging from Project Management, Process Management and 5 years of Line Management experience. Broad experience in multiple therapeutic areas and all phases of clinical trials. Track record of meeting team leadership, productivity, and quality metrics, with demonstrated success in:• Process Mapping and Continuous Improvement• Functional Oversight of CROs• Business Performance Management• Team Engagement & Retention • Innovative Solutions • Cross Functional Expertise and Collaboration• Managing & Implementing Change• Training & Mentoring• Proposals Development and Bid Defenses• Managing Client and Site Partnerships• Affiliate ExpertiseSolid knowledge of ICH GCP guidelines, US FDA and Latin America regulations, EU GDPR and CTR.Contribution to wider Biogen community as a Co-Lead of WIN-Cambridge Chapter.
Experience
Sr Manager, Study Start up Pm
Oct 2023 — Present · US
Education
USP - Universidade de São Paulo
Bachelor's degree, Pharmacy and Biochemistry
2002 — 2008
Babson College
Executive Education - Certificate, Mastering Generative AI in Business
Insper - Instituto de Ensino e Pesquisa (antigo IBMEC Sao Paulo)
Certificate in Business Administration, Business Administration
2009 — 2011
Skills
- Clinical Research
- Oncology
- Áreas Terapêuticas
- Pharmaceutical Industry
- CRO
- Ich-Gcp
- Gcp
- Ctms
- Regulatory Submissions
- Regulatory Affairs
- Clinical Development
- Clinical Trials
- Desenvolvimento De Medicamentos
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.