Heidi Miller Email & Phone Number

Canada

Osaka, Jp

Osaka, Jp

Responsible for providing leadership and oversight on projects ranging in size of complexity from single service to full-scope studies. Oversight of global projects/programs and provides guidance to study teams (including other functional teams). Ensures regulatory compliance and profitable project delivery.Leading and oversight of study teams at Bid Defences, Kick-off Meetings, Governance ( regional and global). Extensive financial experience in development of complex change orders, study and site budgets. Leading, strategizing and contributing in development of proposals and bids for RFPs. Contributes in the development of financial tools. Line management responsibilities (all PMs reporting directly) and mentoring other team colleagues (PD, CTM, CRA, CTA). Represent corporate at conventions.

Osaka, Jp

See description of Senior Project Director Accelovance became Linical Accelovance and than Linical America’s as a result of a merger.

Osaka, Jp

Responsible for leading global and regional Oncology teams.Phase 1 and 3 clinical trials. Empower teams to be innovative on managing challenges. Mentoring staff

Raleigh, North Carolina, Us

Global Project Manager for Phase l study with advanced cancers and Non Hodgkin lymphoma. Accountable for finance and successfully lead functional teams of all deliverables. Proactively identify risks and manage issues. Implement resource strategies to achieve project goals. Excellent internal and external stakeholder relationships. Ensure studies are conducted in compliance with GCP, relevant SOP's and regulatory requirements.Previously, -Global lead for Phase ll study with advanced malignancies.-Accountable of all project deliverables in North America and Latin America for Phase lll Global Ovarian Oncology Studies. Present at external meetings. Participate in bid defence meetings.

Raleigh, North Carolina, Us

Successfully met regional subject recruitment and database lock timelines on a Phase III Epilepsy Study. Effectively managed and lead the development and implementation of a service project to sponsor involving departmental, cross functional and multi-regional teams focused on the delivery of projects.Developed and implemented the program plan, protocol, project plan, resource requirements and study timelines.Maintained effective communication with the Sponsor through oral and written correspondence.Managed regional change in scope.Managed Investigator Payments based on visit schedules, CRF completion and other fees in accordance to executed Clinical Trial Agreements.Worked with Clinical Team on reviewing subject status and enrollment, handles site issues, non-compliance and CTMS compliance. Ensured the project team fulfills their project plan responsibilities in accordance with scope of work and project plan along with proactive risk management and contingency planning.Performed GAP analysis for essential documents ensuring regulatory compliance and working with Document Management and Regulatory group. Developed tool for TMF reconciliation and lead global team in completing this deliverable. Presented at Investigator Meeting in addition to participating at Sponsor Quarterly Meetings.

Raleigh, North Carolina, Us

Managed all aspects of clinical trial conduct from start-up through close out and clinical study report. Extensive experience in managing budget, scope, timelines, resources, quality and risk for Phase I - Ill domestic and global oncology drug studies. Effectively coordinated multi-disciplinary teams for clinical trial services including project management, clinical operations, feasibility studies, medical and safety monitoring, pharmacovigilence, medical writing, data management, central lab, interactive voice response system, electronic data capture and clinical supplies.INC acquired MDS Pharma Services on July 1, 2009.

King Of Prussia, Pennsylvania, Us

Please read INC Research Description.

Montreal, Quebec, Ca

Trained and managed a team of seven Clinical Research Associates.Involved with multiple projects and different responsibilities (training-developing training plans, monitoring, CRF/protocol review, study start-up activity, database lock).Extensive experience in Investigator Initiated Studies.

New York, New York, Us

Collected data for Serious Adverse Events from Canadian sites, followed up with investigators and disseminated information to the project teams.Trained new employees about Pharmacovigilence.Collaborated with Global Safety on global clinical trials.Performing on-going management of a CRO who provided 24-hour safety coverage.

Montreal, Quebec, Ca

Monitoring activitiesCreating and preparing study materialsInvolved with protocol development.Wrote CSR (Anaesthesia) that was submitted to Health Canada

Monitoring Oncology (solid tumor, hematology) and Endrocine studies from site activation to closure of study sites.Supervised and trained newly assigned staff.

Managed patients on Phase l-lll Oncology clinical trials and Phase ll Cardiology clinical trials.Created patient information sheets about management of their disease and treatment.Collaborated with pharmaceutical companies and CROs.

Bscn, Health Sciences

Nursing Diploma, Nursing