Donna Heck Email & Phone Number

United States

US

• ExecuPharm, now part of Parexel is a global CRO / Biopharmaceutical Company.The company provides pharmaceutical consulting services to large and small companies. Lead day to day clinical operations for Three advanced.
• Managed the US study team of CRAs, Finance and Regulatory managers and Clinical Trial Associates.
• Expert in developing and improving study documents including Monitor Plan, Recruitment Plans, Study Newsletters, and Institutional Lead Clinical Reseach manager documents.
• Drove the execution and performance of deliverables/timelines/results, ensuring commitments from feasibility through to closeout were successful.ACCOMPLISHMENTS - Successful management of Phase IIb advanced gastric.

US

• Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.Assigned to Sanofi Oncology Clinical Unit. Manage the on-time execution and conduct of three.
• Create and update study-specific documents such as Monitoring Guidelines, Site Feasibility questionnaires, Satellite Site Management Plan, Inform Consent Form, IMP related documentation, and Study reference manuals for.

• ICON is a global provider of consulting, and outsourced development and commercialization services to pharmaceutical, biotechnology, medical device and government and public health organizations. Senior CTM responsible.
• Manage coordination of subject enrollment during dose escalation phase. Assist with preparation of Dose Escalation Presentations and Meetings.
• Manage study vendors (IVRS, Laboratories, Imaging and ECG). Ensure vendors adhere to contractual obligations, and complete change orders as needed. ACCOMPLISHMENTS- Assigned as Vendor SME which included Oncology.

• Lead MRA for three Phase III oncology trials. Manage study sites in all aspects, including start-up activities, study maintenance and close-out.
• Data Review; including cross-check of internal and external data sources for accuracy and consistency. Track and resolve missing lab samples.
• Manage CAPAS and quality issues in response to process and site audits.

Project Trial Manager for Phase IIb global trial, and Lead Trial Specialist for out-sourced Phase II and III global trial.Manage CRO for out-sourced study, maintain responsibility matrix, and ensure all activities from start-up to close-out meet timelines and requirements. Oversee all internal functional areas; ensuring all study activities are integrated.

Maintain working relationship with clinical sites; assist with co-monitoring and quality visits. Review trip reports and takes corrective action as appropriateAssist with development of Monitor Plan, Vendor Oversight Plan, Communication Plan and other study documents. Provide clinical input on CRF, CRF completion guidelines and other study related.

Pmp Certification, Project Management

Activities and Societies: PMI Member

Bachelor'S Degree, Psychobiology