In dual role for niche CRO, direct pharmaceutical drug development projects / trials (primarily but not exclusively government-funded). Oversee Clinical Project Manager and cross-functional study team in execution of clinical studies in compliance with GCP, ICH, corporate policy – study design, scheduling, critical path, milestones, study status updates, reporting. Concurrently, manage full clinical and regulatory document function – structure, content, format, and compliance to regulatory… Show more In dual role for niche CRO, direct pharmaceutical drug development projects / trials (primarily but not exclusively government-funded). Oversee Clinical Project Manager and cross-functional study team in execution of clinical studies in compliance with GCP, ICH, corporate policy – study design, scheduling, critical path, milestones, study status updates, reporting. Concurrently, manage full clinical and regulatory document function – structure, content, format, and compliance to regulatory guidelines. Define or approve all documentation; e.g., protocols, clinical trial reports, IND documentation, regulatory submissions / responses. Handle vendor selection and oversight for both. • Led cross-functional teams / individuals in development of 5-10 grant and contract proposals per year.• Outperformed funding goals for both clinical and non-clinical research and development.• Credited with accelerating project delivery on clinical and nonclinical trials up to 20% by identifying both risks and roadblocks and taking direct action to address. Show less

Managed projects with heavy focus on grant submissions, clinical regulatory documentation, and scientific publication writing. Supported clinical teams with medical writing expertise and preparation / review of clinical regulatory documents and submissions (e.g., for filings and dossiers) as well as publications.• Introduced cross-functional project meetings personnel that progress according to timelines and budget.• Identified 10 new funding opportunities and led 4 successful grant… Show more Managed projects with heavy focus on grant submissions, clinical regulatory documentation, and scientific publication writing. Supported clinical teams with medical writing expertise and preparation / review of clinical regulatory documents and submissions (e.g., for filings and dossiers) as well as publications.• Introduced cross-functional project meetings personnel that progress according to timelines and budget.• Identified 10 new funding opportunities and led 4 successful grant submissions.• Reduced target vendor costs 25+% with optimized vendor identification, selection and management.• Managed project teams to 100% on-time completion of grants and related contracts. Show less

Promoted to handle high volume of fast-changing project requirements, documentation and IND submissions for 6 grants.

Recruited as undergrad and fast-tracked from Project Assistant (clinical trial master files) to Project Associate (grant submissions, FDA submissions, drug development support, and GCP).