Megan Schaeffer Email & Phone Number

Philadelphia, Pa, Us

Leads the implementation of the clinical development plan for Geron's clinical-stage programs.Primary Responsibilities:1. Provide strategic and tactical leadership, oversight, and support to the Oncology Clinical Operations team for the implementation of the clinical development program and be accountable for all Clinical Operations deliverables associated with the program including timelines, budget, vendor oversight, and data quality2. To manage, support, train, and mentor the… Show more Leads the implementation of the clinical development plan for Geron's clinical-stage programs.Primary Responsibilities:1. Provide strategic and tactical leadership, oversight, and support to the Oncology Clinical Operations team for the implementation of the clinical development program and be accountable for all Clinical Operations deliverables associated with the program including timelines, budget, vendor oversight, and data quality2. To manage, support, train, and mentor the Clinical Operations staff members to the highest quality of output3. Lead Clinical Operations Team Show less

The Executive Director, Clinical Operations is responsible for:Provide strategic and tactical leadership, oversight, and support to the Oncology Clinical Operations team for the implementation of the clinical development program and be accountable for all Clinical Operations deliverables associated with the program including timelines, budget, vendor oversight, and data quality.To manage, support, train, and mentor the Clinical Operations staff members to the highest quality of… Show more The Executive Director, Clinical Operations is responsible for:Provide strategic and tactical leadership, oversight, and support to the Oncology Clinical Operations team for the implementation of the clinical development program and be accountable for all Clinical Operations deliverables associated with the program including timelines, budget, vendor oversight, and data quality.To manage, support, train, and mentor the Clinical Operations staff members to the highest quality of outputCarries out direct supervisory responsibilities in accordance with the department-set goals.Responsibilities include interviewing potential employees; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution. Show less

Accountable for:Ensuring an effective Compliance program is established and proper internal controls are in place and support business compliant solutions.Promoting a values-based compliance culture through communication and training. Supporting early and proactive identification of risks in all aspects of the designated area’s strategy and activities. Advising senior leaders on risk associated with emerging business strategies and pragmatic options for risk mitigation.

I support within Oncology, our Biomarker Team, Early Development and Discovery teams as it relates to Quality Management. I am involved in the development of a Quality Assurance Plan to conduct Assessments at our laboratory vendors. In addition support all Data Integrity efforts within the team. I am accountable to ensure the correct compliance checks are executed prior to engaging in external engagements. I support our scientists, chemists and study teams as it relates to any quality… Show more I support within Oncology, our Biomarker Team, Early Development and Discovery teams as it relates to Quality Management. I am involved in the development of a Quality Assurance Plan to conduct Assessments at our laboratory vendors. In addition support all Data Integrity efforts within the team. I am accountable to ensure the correct compliance checks are executed prior to engaging in external engagements. I support our scientists, chemists and study teams as it relates to any quality issues raised and work to ensure correct action plans are put in place and issues are brought to resolution. I support any internal inspections or external audits. I work to ensure quality is maintained within our day to day activities and determine proactive approaches to identifying risks and embedding solutions and embed quality from the on set. Show less

As a result of the organizational changes within Oncology, my role has expanded to have Global oversight of Monitoring for the unit. Work to liaise with our LOCs globally to help support monitoring. Support study teams to ensure achievement of milestones. Part of Quality group within unit in a matrix environment to help trouble shoot, ensure lessons learned across the unit globally, support compliance inspections and resolution of. Manage and support resourcing needs globally. Forecast… Show more As a result of the organizational changes within Oncology, my role has expanded to have Global oversight of Monitoring for the unit. Work to liaise with our LOCs globally to help support monitoring. Support study teams to ensure achievement of milestones. Part of Quality group within unit in a matrix environment to help trouble shoot, ensure lessons learned across the unit globally, support compliance inspections and resolution of. Manage and support resourcing needs globally. Forecast global resourcing needs. In early 1Q2011 was transferred oversight of productivity/simplification team within Oncology. Goal is to focus on areas of improvement and partner with broader R&D on simplification. Show less

Oversight of the oncology dedicated US CRAs. Responsibilities include but not limited to, line management of CRAs, LCRAs and Monitoring Managers, oversight of department of 42, Department budget management, to deliver all phase II-IV clinical trials in the US for Oncology R&D and Oncology Vaccines to ensure strategic global delivery of required clinical trials to support NDAs (New Drug Approval for FDA), MAAs (Marketing Authorizations in Europe) and global submissions. Also delivers… Show more Oversight of the oncology dedicated US CRAs. Responsibilities include but not limited to, line management of CRAs, LCRAs and Monitoring Managers, oversight of department of 42, Department budget management, to deliver all phase II-IV clinical trials in the US for Oncology R&D and Oncology Vaccines to ensure strategic global delivery of required clinical trials to support NDAs (New Drug Approval for FDA), MAAs (Marketing Authorizations in Europe) and global submissions. Also delivers USP-funded trials to support the US business marketing strategy. Create and maintain effective partnerships with CCSE, other Monitoring head(s), Study Management, RMS group and matrix partners within the MDCs Show less

Main responsibility within this position was for the oversight of an oncology asset during its clinical life cycle. This included oversight of the clinical trials including management of the staff running the day to day operations of the programs. Was part of strategy and indication developing for tumor types within the asset.

In this role, I was responsible for the oversight of 17 projects, across the following therapeutic areas of Dermatology, GI, Pain and Immunology. The day to day operations of these programs are managed by the Project Manager.My responsibilities included:• Focus on projects and own them through all deliverables• Escalation pathway for the project teams• Development and maintenance of client communication and relationships• Mentoring direct reports• Assume end to end… Show more In this role, I was responsible for the oversight of 17 projects, across the following therapeutic areas of Dermatology, GI, Pain and Immunology. The day to day operations of these programs are managed by the Project Manager.My responsibilities included:• Focus on projects and own them through all deliverables• Escalation pathway for the project teams• Development and maintenance of client communication and relationships• Mentoring direct reports• Assume end to end responsibility for customer managementIn addition to the task listed for prior role. Show less

My responsibilities within this role included, direct reports of 3 clinical studies with a combined staff of 17 employees, including, responsibility for training, mentoring, and performance reviews.In addition to management of studies, responsibilities include:• RFP review and bid/contract development and submissions• Budget oversight and management for ongoing studies• Client presentations for bid defense meetings• Manage all aspects of directly assigned projects and… Show more My responsibilities within this role included, direct reports of 3 clinical studies with a combined staff of 17 employees, including, responsibility for training, mentoring, and performance reviews.In addition to management of studies, responsibilities include:• RFP review and bid/contract development and submissions• Budget oversight and management for ongoing studies• Client presentations for bid defense meetings• Manage all aspects of directly assigned projects and provide administrative, clinical and fiscal oversight.• Supervise project managers, monitors, and support staff on project teams• Oversight and management of office in conjunction with 1 other Associate Director• Responsible of interviewing and hiring of new staff for the office• Preparation for Project Review / Executive Review meetings• Involved with termination of employees, as needed• Bid review meetings during the RFP process• Involved in development and execution of office training• Mentor new hires to get acquainted with company• Management of office resourcing to ensure adequate staffing across current programs• Conduct Manager meetings with current PM/CTM’s Show less

Responsibilities within this role included, managing a phase II/III GI protocol from start-up through final report. The trial involves 58 centers in the US/Canada and targeting enrollment at 500 patients. The project team consists of 6 FTE CRAs, 0.5 APM and 1.5 RA. The study is projected through May 2006. Overall responsibilities include: track and manage budgetary issues for project, participate in project Team and Executive Review Meetings to communicate progress of studies, quality issues… Show more Responsibilities within this role included, managing a phase II/III GI protocol from start-up through final report. The trial involves 58 centers in the US/Canada and targeting enrollment at 500 patients. The project team consists of 6 FTE CRAs, 0.5 APM and 1.5 RA. The study is projected through May 2006. Overall responsibilities include: track and manage budgetary issues for project, participate in project Team and Executive Review Meetings to communicate progress of studies, quality issues, budgetary issues, and operational concerns, manage study related activities to include: project hour allocations, review of protocol, ICF’s and CRF, critical document collection, investigator meeting presentation, over all study tracking, supervise monitoring and support staff on project teams. In addition, ensure project team completion of PPD and sponsor procedural documents. Show less

Main responsibility involved oversight of the trials from the start to completion. Trial experience included pediatric ID trials and Dermatological Trials. The role of the PM at CPR is to facilitate trial maintenance, oversight of all trial related activities and departments to ensure on time and within budget trial delivery. In addition, I am responsible for SOP development and sign-off of SOPs.Project Manager• Manage a staff of CRAs• Primary contact with client• Direct… Show more Main responsibility involved oversight of the trials from the start to completion. Trial experience included pediatric ID trials and Dermatological Trials. The role of the PM at CPR is to facilitate trial maintenance, oversight of all trial related activities and departments to ensure on time and within budget trial delivery. In addition, I am responsible for SOP development and sign-off of SOPs.Project Manager• Manage a staff of CRAs• Primary contact with client• Direct reports from additional departments within CPR (i.e. Finance, Site Selection, Resource Allocation and Regulatory).• Responsible for study start up• Ensuring on time delivery of trial• Report review• Weekly tracking of study and related documents• Budget facilitation• ICF and Document review and approval• Conduct Kick-off and Product Targeted Training • Ensure enrollment, monitoring visit and trial in on time and in accordance with the contract• Contract review Show less

Employment with AstraZeneca was in the GCQA System and Process Group. Responsibilities involved auditing facilities prior to or during their use by AstraZeneca clinical teams.Clinical Quality Assurance Advisor• Conduct CRO / Laboratory Audits• Conduct System audits of Marketing Companies and CROs• Proposal Reviews• For – Cause audits

Maintain responsibilities of a lead auditor as outlined below• Training of new staff• Request for Proposals (RFP)• Host Sponsor Meetings / Audits• Attend Business development meetings for new proposals• Manage auditor staff• Assist with ISO registration / maintenance of registration• Assist with integration of new company (i.e. SOP review)• Conduct manager Review Meetings

• Lead auditor for studies (continue audits as outlined below)• Assisted in the acquisitions of a new company• Statistical Report Audits• System Audits• Vendor Audits• Assist corporate training department• Conduct Quality Review Meetings

• Lead auditor for ICON studies• Study File Audits• Monitoring File Audits• CRF, Protocol, and ICF review• Critical Document Review prior to drug release• Database Audits • Tables and Listings Review• Site Audits• Report Writing / Query Generation• Ensure SOPs, SSPs, ISO 9002, ICH and GCP are being adhered to

Initiate and monitor clinical studies; collect pre-study documents; evaluate investigator eligibility; maintain clinical investigator files; develop clinical SSPs; initiate shipments of clinical supplies; audit study documentation; ensure compliance with GCP guidelines.

During this role, I conducted Placement, Initiation, and Monitoring visits at the sites in the United States and Canada. This involved monitoring of site Source Documentation and Case Report Forms, preparation and participation in an ISO 9000 audit, maintenance of study activities including, Monitor, Pharmacy, Site and Study Binders completion and filing. In addition ensure preparation of regulatory packages and documents for QA approval, including review of informed consents, IRB approval, and… Show more During this role, I conducted Placement, Initiation, and Monitoring visits at the sites in the United States and Canada. This involved monitoring of site Source Documentation and Case Report Forms, preparation and participation in an ISO 9000 audit, maintenance of study activities including, Monitor, Pharmacy, Site and Study Binders completion and filing. In addition ensure preparation of regulatory packages and documents for QA approval, including review of informed consents, IRB approval, and site approval, document submission for Canadian HPB approval and responsible for, drug shipment and drug accountability. In this time, I was promoted within five months from a Clinical Research Assistant to a Clinical Monitor. Show less

Quality Control of Case Report forms and acted as liaison with sites. Organization of client files. On a routine basis I provided in-house support to clinical team to ensure the successful delivery of clinical trials.