Amy Kramer Email & Phone Number

Philadelphia, PA, US

Delaware, United States

• Provides Director level project management support as a consultant to biotech and pharma clients to support their clinical operation needs.
• Ensures the timely execution of clinical trials with a focus on quality deliverables.
• Ensures project risks and potential contingencies impacting time/quality/cost
• Identifies issues encountered during a clinical trial and proposes strategies for preventing or correcting significant problems.
• Engages external network to provide solutions, helps contract with and negotiate for required services, and provides oversight of selected vendors.
• Development and contribution to SOPs, internal ways of working and establishing processes to support overall departmental growth within the organization.

• Clinical operation project manager for assigned clinical studies including selection and oversight of full service CROs. Oversees on time study deliverables of key milestones. Establishes vendor management plans and.
• Manage study financials including vendor work order development and approval, invoice review, monitoring spends, facilitate regular forecasting communication between Finance departments. Manages vendor work order.
• Active participant in CRO lead meetings, including regular CRO study team meetings and protocol training, responsible to review key CRO study operational plans, proactively provides input to operational strategy.
• Tracks study progress and proactively escalates project related issues, including related to time, budget, and quality, to the key internal stakeholders to ensure timely resolution of issues.
• Leader of internal cross functional study team; manages, facilitates and documents meetings (e.g., action log) and facilitates effective decision making, cross functional connectivity, and communications are effective.
• Ensures comprehensive operational input to protocol design.

• Oversight Director, Vaccines therapeutic area
• Ensures the timely execution of clinical trials with a focus on quality deliverables.
• Ensures project risks and potential contingencies impacting time/quality/cost
• Identifies issues encountered during a clinical trial and proposes strategies for preventing or correcting significant problems.
• Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the location/division at appropriate professional.
• Fosters client relationships and supervise strategic sell initiative of the division.

• Vaccines Therapeutic Area
• Plan and implement, to achieve, anticipated and unexpected project deliverables.
• Analyze and oversee cost, personnel hours and project needs to determine the most cost effective and efficient means to run and complete projects successfully on time, to agreed quality standards and within budget.
• Delegate assigned responsibilities to project team members.
• Have regular and proactive liaisons with Department Heads to optimize performance and utilization of the project team members.
• Anticipate potential issues and escalate appropriately/pro-actively to their Franchise Director.

Decentralized

Responsible for the overall coordination and management of clinical trials from start up through close out activities. Directs the technical and operational aspects of the projects -- thus securing the successful completion of clinical trials. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data.

Home Based

Client Liaison - Internal, external and vendorsProject Initiation & Planning - Manage start up activities - Provide input and/or develop project tools and plans - Site selection - Recruitment planning - Team member trainingProject Implementation, Control & Evaluation - Provide leadership and direction to team members - Resourcing - Productivity targets and.

• Responsible for overall study coordination following ICH/GCP guidelines
• Experience in providing oversight for large global vaccine trials (18+ countries) with a large subject population (30,000+)
• Experience managing Local Operating Companies located in EU, APAC, NA, LatinA, and Emerging Markets.
• Project management of global trials from pre-study activities to study completion, including timelines and budget
• Analyze and evaluate the feasibility and consequences of design proposed in regard to procedures
• Work across study teams to develop monitoring guidelines, study procedure manual, and study specific documents and user guides

Biologicals - VaccinesProvided study management support for global vaccine trials.

I worked in Early Stage Development on Phase 1 Oncology Trials, specifically haematologic malignancies. Provided in house site management support for sites in 4 countries.

• Phase I-III national and international trials.
• Participate in the coordination of and contribute to Study Delivery activities to ensure quality and consistency of SD deliverables to time, cost, and quality objectives from Study Design Concept through database lock.
• Collect, review and track regulatory and other relevant documents. Interfaced with Investigators, CROs and Marketing Companies during the collection process to support effective delivery of a study and its regulatory.
• Responsible for the set-up, population and maintenance of information in AstraZeneca tracking and communication tools and support others in the usage of these systems.
• Contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors.

Provided regulatory support and site management for studies in the following therapeutic areas: oncology vaccinesTrained those in the position of CTA I and CTA II.

Provided regulatory support and maintained databases and files for oncology trials in the US.

Document Collection and trackingQC and audits of files to prepare for FDA filingDistribution of site materials and documentsAdministrative duties

Msm, Health Care Administration

MSM/Health Care Administration

Bsba, Bus Admin/Marketing

Activities and Societies: VP American Marketing Association, VP Fundraising American Marketing Association, Treasurer Women's.