Meena has over 25 years of experience in project management, strategy and partnership development, data management and operations leadership in the CRO, medical device and pharmaceutical industry. Before joining ClinSmart, she served as Senior Project Manager at Bio-Imaging Technologies, now BioClinica.
Meena has a balanced perspective on the industry having held several positions with both big pharma and specialty start-up companies.
She is heavily involved in her community and abroad and continues to direct Bengali Kids of Princeton Area, a non-profit education and cultural society founded by her children. Meena has a passion for mentoring and character building and often accompanies area youth as far as Mother Theresa’s Orphanage in India to help develop values.
Dawn Serkin, RN, BScN
Ms. Serkin has over 25 years of experience in clinical research. She has obtained a mix of pharmaceutical and CRO clinical trial experience in all phases of the research process. This includes experience in a variety of therapeutic areas along with a pharmacovigilance and data management background.
Additionally, Ms. Serkin has held nursing positions ranging in capacity from Head Nurse of Intensive Care/Coronary Care, Cardiovascular Clinical Nurse Specialist to Director of Nursing for a high-tech home care company.
Certifications include Regulatory Compliance and GCP; Clinical Research (Coordinator/CRA); Human Subjects Protection Certification; Informed Consent and Assent; Certification in Oncology from Fox Chase Cancer Center; Critical Care Nursing by Board Exam and Nursing Management from the University of Pennsylvania.
Jamie Chen, MD
Medical Safety Officer
Dr. Chen has over 20 years of experience in the pharmaceutical industry, that includes participation in 3 FDA and 5 vendor audits. Positions held include Department Head, CDISC, STDM lead, and Associate Director of Data Management for a US pharmaceutical company, as well as, management in a CRO setting. She has extensive experience in medical coding; safety review, ePRO, SAE reconciliation and system validations. She has built up a CDM department and led EDC system architecture development for a CRO company.
Dr. Chen is experienced in Safety review, safety report, Medical coding, full Data Management function, Quality Assurance, and external vendor management.
Therapeutic areas include Oncology, Neurology, Woman Health, Infection Disease, Urology, Immunology, CNS, Dermatology, Cardiology, Surgery Transplantation (Liver), and Medical Device experience in adult population. She is also the lead for pediatric study in oncology, genetic and CNS. Dr. Chen has received her Master Degree of Science and Medical Doctor Degree at Peking Union Medical College.
Raymond E. Tobey, MD
Chief Medical Officer
John E. Higson, MBA
Director, Project Management
Michael F. Miller, PhD
Director, Biostatistical & Quantitative Analysis
James L. Perhach, PhD, FCP
Director, Clinical Development & Research
James Perhach is an accomplished clinical research professional and Fellow of the American College of Clinical Pharmacology with over 25 years of experience in drug development and approval in neurotherapeutics, analgesics, respiratory and other areas including commercial support programs. Prior to joining ClinSmart he developed, implemented and monitored yearly clinical trial budgets of over $100 million.
Dr. Perhach continues to focus on optimizing clinical development strategy to provide evidence of efficacy to support continued clinical development and demonstrate commercial value of the product at the time of submission.
Jim is an avid Pitt fan, and you can often find him cheering for his favorite team. He also enjoys the finer things in life like sketching and painting with an iPad.