Sylvia S. Singh

Manage Project Coordinators (4 FTEs) within Medical Writing department, oversee their daily tasks and compliance with company policies and procedures.

• Manage organization, completion and assembly of raw data, and constituent reporting while overseeing process improvements.
• Empower employees to take ownership of their responsibilities, leading to increased accountability and improved performance outcomes.
• Production, maintenance, and weekly updates of CBSET deliverable tracking tools (Zoho Projects & Microsoft Office).
• Participate in study-specific pre-initiation meetings; suggest courses of action for data collection enhancements or protocol edits.
• Reduced turnaround time for project completion through effective resource allocation and team management.
• Conduct regular performance reviews, identifying areas for improvement and developing action plans to address them.
• Lead hiring, onboarding and training of new hires to fulfill business requirements.
• Collaborate with other departments within organization for seamless integration on cross-functional projects, ensuring clear understanding of responsibilities and expectations.
• Create comprehensive documentation for each phase of project life cycle, ensuring all relevant information is accessible for future reference or audits.
• Analyze project costs to confirm positive return on investment (ROI) for new proposals.
• Enhance team productivity by providing comprehensive training on project management tools and methodologies.
• Facilitate smooth collaboration between departments through clear communication channels.

• Participated in the general data overview during procedures as appropriate (i.e., Quality control of In-Life data in accordance with SOP, GLPs, and protocol standards).
• Generated In-Life tables for Final Report deliverable.
• Completed In-Life Quality Assurance Inspection Reports in a timely manner.
• Assisted Medical Writers in compiling GLP and non-GLP protocols for Clients and Study Directors.
• Compiled Deviations for GLP and non-GLP study protocols as necessary.
• Enhanced team collaboration through regular meetings, fostering a positive work environment for increased productivity.
• Liaised between departments to facilitate communication on project developments.
• Managed approximately 280 reporting deadlines annually and adjusted workflows as needed to keep project submissions on time.
• Administered project management meetings to align support staff priorities with management goals & gathered support material.
• Identified potential risks and developed mitigation strategies to minimize impact on project success.
• Increased profit by streamlining operations with Electronic Data Capture (EDC).
• Functioned as primary liaison between Technical Operations, Quality Assurance, and Medical Writing management staff, leading seamless coordination between teams.

• Monitored several active protocols including Molecular Inheritance of Reproductive Disorders, Bosma Arhinia cohort and DISGUST study.
• Managed respondent outreach to confirm participation via phone and email contact
• Increased recruitment of subjects by 72% through postcards / brochures / letters.
• Verified patient eligibility via chart abstraction using various electronic medical records (EPIC, CAS, Partners On Call) and clinical analysis of case data.
• Assisted in design & preparation of study protocols, case report forms, informed consent forms, and annual progress reports for IRB renewal as necessary.
• Created pedigrees in Progeny database using phenotypic data collected from patient questionnaires, smell tests and phone conversations with proband and family members.
• Monitored and reported adverse events as required by institutional/federal regulations.
• Demonstrated adaptability by managing diverse datasets across various disciplines successfully.
• Participated in project status update meetings, keeping stakeholders apprised of ongoing data collection efforts and preliminary results.

• Monitored safety events during clinical trials by promptly reporting adverse events and implementing corrective action plans as needed for Look AHEAD Study, Diabetes Prevention Program Outcomes Study (DPPOS), REDUCE-IT Study and Cortical Plasticity Study (collaboration at Beth Israel Deaconess Medical Center).
• Participated in site monitoring visits, addressing any concerns or discrepancies related to patient enrollment or data collection procedures.
• REDUCE-IT Study: Recruited approximately 80 patients using flyers/brochures, consented and scheduled patient visits, administered study forms and questionnaires and completed data entry using Trident Bioclinica System.
• LookAHEAD Study and DPPOS Study: Consented patients during scheduled visits, administered EKGs, questionnaires, Neuropsychology Cognitive tests and Physical Function tests.

• Knowledge and compliance with HIPAA guidelines.
• Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
• Contributed to the publication of 5 high-impact research articles, showcasing the significance of the findings.