Ann Willer

• Served as Regional Head of Clinical Monitoring for the Americas for Caidya (formerly Clinipace), moving from Director to Senior Director level during tenure.
• Responsible for the oversight and leadership of Clinical Monitoring for the Americas including direct management of CRA Line Managers. Reporting line included over 70 direct reports and was the largest reporting group in the organization.
• Collaborated with leadership team to ensure high quality oversight to achieve metrics
• Liaised closely with QA to support multiple activities including audits and inspections
• Was a member of a cross-functional leadership team supporting review and updates to Caidya’s SOPs, Guidelines and associated controlled forms.
• Worked cross-functionally liaising closely with members of Clinical Management and Central Monitoring Leadership for effective planning, execution and leadership of the clinical portion of trials.
• Partnered closely with Recruiting to recruit and hire top quality candidates.
• Supported business development activities including the development of clinical portion of budgets and proposals.

Achievements:

• As a member of a small global clinical director team, performed a full overhaul of Caidya’s Clinical Monitoring SOPs, Guidelines, and Forms.
• Provided training on various topics to the Clinical Management and Project Management teams during monthly team meetings
• Updated CRA hiring tools to support improved candidate selection

• Management and supervision of Clinical Research Associates, National Lead CRAs, Global Lead CRAs and Oversight Leads in the United States and Canada across dermatology clinical trials including hiring, resourcing, and quality visits
• Alignment with global pivotal trials to provide management guidance to support successful execution
• Liaison for vendor partners for insourced Global Site Management Staff managing the partner relationships to achieve mutual goals
• Liaison for LEO US MSL team to support effective communication between trial teams and the MSL team
• Interviewing and hiring of Global Site Management staff including CRAs and managers
• Training and onboarding of new CRAs and Leads
• Ongoing development of staff
• Mentoring and ongoing support of less-experienced managers
• Support for regulatory inspections of LEO and LEO sites
• Leader and participant in multiple initiatives to improve quality and efficiency
• Close collaboration and communication with other managers in Global Site Management and R&D globally

Achievements:

• Served as an organizer and a presenter for a highly successful international collaborative meeting between three large LEO functional areas in R&D
• Manager aligned with the first two LEO pivotal trials in a biologic. Both trials had accelerated timelines and achieved on-time database locks.
• Successful rapid ramp-up of hiring to meet staffing needs for pivotal trials
• Supported highly successful new CTMS implementation

• Provided functional management and supervision of Clinical Operations employees. Managed a blended team of CRAs, Clinical Team Managers and In House CRAs leading as many as 27 direct reports.
• Progressed from Manager to Senior Manager level during tenure at PRA.
• Identified, mitigated, and escalated potential risks to the company or individual projects or programs.
• Ensured staff fulfilled their responsibilities in accordance with policies and procedures, SOPs, ICH-GCPs and regulatory requirements.
• Developed assigned employees to ensure optimal performance and retention of high-quality employees.
• Participated in quality efforts for continuous improvement by ensuring quality metrics were in line with company, client, and clinical operations objectives
• Assessed Clinical Operations employee resources and employee resource projections to ensure that project teams meet client expectations and contractual obligations
• Reviewed project tasks, provided leadership in the delivery of services to clients
• Recommended and implemented Clinical Operations performance and productivity improvements to optimize utilization of billable staff
• Identified and implemented process improvements to optimize employee performance
• Partnered with Human Resources regarding staff performance issues
• Conducted interviews for Clinical Operations employees and managers
• Trained new “Bridge CRAs” in oncology monitoring

Achievements:

• Member, Clinical Quality Improvement (CQI)
• Peer mentor for Clinical Operations Managers
• Clinical Operations Leadership for Sponsor Audits of PRA
• Collaborated with PRA IT to create new application on Salesforce platform to track and trend site audits and audit responses globally.
• Clinical Operations Leadership and Oversight for Site Audit Response Reviews
• Leadership of global team for development and review of Quality Best Practice (QBP) documents
• Presenter, Research Support Coordinator Program: Good Clinical Practices; Clinical Operations Overview
• Presenter, CTM Group, Communication in Teams
• Mentor for Research Support Coordinators
• Mentor for CRA and In House CRA Managers

• Managed Clinical Research Associates and Protocol Team Leads in accordance with Client’s SOPs and business practices and applicable regulations.
• Responsibilities included: planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees, addressing employee relations issues, and resolving problems.
• Participated in the selection and on-boarding process for new CRAs by conducting candidate review and participating in the interviewing process.
• Assisted with on-boarding training for new staff in conjunction with trainers.
• Ensured that staff had the proper materials, systems access, and training to complete job responsibilities.
• Provided oversight for the execution of the training plan, SOP review and mentored training experiences.
• Participated in the allocation of resources to clinical research projects by assigning staff to clinical studies that were appropriate to their experience and training.
• Managed the quality of assigned staff’s clinical work through regular review and evaluation of work product.
• Identified quality risks and issues and created appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Ensured that staff met defined workload and quality metrics through regular review and reporting of findings
• Provided leadership for quality and process initiatives.
• Completed bi-annual on-site quality visits with assigned team members; most on oncology protocols

Achievements:

• Mentor for new Clinical Operations Managers
• Presenter at Amgen FSP National Meeting
• Project team leader for manager trip report quality review team; process trainer
• Developed and presented oncology monitoring program for ACE CRAs

• Managed the execution of the clinical component of large, complex study protocols and global projects in accordance with the scope of work, contracted timelines, and study budget.
• Responsible for the clinical oversight and execution of two large global Phase 3 programs. One program included two oncology indications, genitourinary cancer and non-small cell lung cancer. The other program was for acute exacerbation of chronic bronchitis.
• Oversight of Clinical Team Leads included the quality execution of global trials from feasibility through closure including the tracking of timelines and activities to ensure successful start-up and on-time recruitment globally.
• Provided oversight and leadership across the team for assigned Clinical Team Leads on global projects with multiple assigned Clinical Team Leads in other countries.
• Established appropriate clinical tools and processes for the study team to support the execution of clinical deliverables and study timelines including standard English language templates and tools to be used globally with translations where required.
• Collaborated with other functional groups to support milestone achievement and to manage study issues and obstacles.
• Provided ongoing training and support to the clinical team. Established study tools and training materials to support the successful conduct of the trial.
• Conducted frequent team meetings and ensure regular communication.
• Mentored less experienced Clinical Team Leads.
• Ensured high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site visits and ongoing mentoring of the CRA team.
• Communicated and established a customer service relationship with the Sponsor representatives.

• Managed the global and regional execution of the clinical component of study protocols of medium to high complexity in accordance with the scope of work and contracted timelines. Indications included metastatic colorectal cancer, Crohn’s disease, and irritable bowel disease.
• Trial management encompassed site feasibility through site closure.
• Feasibility activities included development of feasibility questionnaires, liaising with Sponsor MSL team regarding site interest, selection of site list for PSSV and final site selection
• Established clinical tools and processes for the study team to support execution of the clinical deliverables. Responsible for writing the Clinical Management Plan and completion of the trial-specific standard English ICF template using the Quintiles ICF template form. Completion of other trial manuals, guides and tools and review and input to other trial plans. Responsible for design and standard content of Investigator Site File.
• Reviewed eCRFs, provided input to data specifications and wrote eCRF Guidelines.
• Worked collaboratively with other functional groups to support milestone achievement.
• Tracked progress and develop contingency plans when necessary.
• Provided ongoing training and communication for the clinical team.
• Contributed to the quality and risk management plan.
• Tracked clinical budget consumption through regular review of project budget reports.
• Communicated and established a customer service relationship with the clinical client representative.

• Clinical monitoring and site management for clinical trials for multiple oncology indications including metastatic breast cancer and metastatic colon cancer
• “SWAT” visits for neurology protocols
• Responsible for ensuring investigational sites comply with ICH guidelines, FDA regulations and sponsor CRO SOPs
• Lead CRA for a Phase 2b prostate cancer trial and a Phase 1b inpatient secondary AML trial.
• Lead CRA responsibilities included: leading internal project teleconferences and external (Sponsor) project teleconferences; trip report review; CRA training and mentoring; completion of CRF guidelines; review of eCRFs and input to selection of standard eCRFs and design of eCRFs; contribution to data specifications; review of eCRF Guidelines; development of site initiation presentations; investigator meeting preparation and presentation; development of monitoring tools and source documentation worksheets; on-site training; site quality visits with CRAs.
• As a Lead CRA, was responsible for tracking the clinical budget consumption and overall clinical quality of the trial. Responsible for clinical management of trials from feasibility through closeout.

• Clinical monitoring for an oncology vaccine trial for prostate cancer
• Assisted extensively with study start up activities including draft informed consent review, tracking of start-up activities, assisting to collect required regulatory documents, and developing site initiation visit presentations and study tools
• Traveled extensively throughout the country to perform pre-qualification visits, site initiation visits and interim monitoring visits
• Was a member of the training pool conducting on-site training and sign-off visits

• Provided clinical monitoring of multiple oncology trials. Indications included metastatic pancreatic cancer, MDS and genitourinary cancer
• Reviewed informed consent forms and corresponding documentation to assure the rights and well-being of study subjects was maintained
• Provided timely and accurate documentation of all activities performed
• Performed on-site training visits and trip report review

• Telephonic clinical support to patients and clinicians for several chronic health conditions requiring home infusion care including a life-saving orphan drug for primary pulmonary hypertension.

• Oversight of two nursing branches of APS America providing home infusion nursing care to patients in Kansas and Missouri and dispensing and shipping plasma derivatives for home infusion nationwide.
• Responsibilities included hiring and training nursing staff, negotiating payor contracts with insurance carriers, and arranging for home infusion nursing care outside of Kansas and Missouri

• Provided home infusion care (scheduled and on-call) to patients with chronic conditions requiring routine home IV therapy throughout Kansas and Western Missouri.
• Coordinated care with physician’s offices and managed care plans and visit schedules.
• Interviewed and trained nurse specialists.
• Liaison for clinical trials ensuring nurses conducting study visits were trained on the protocol requirements and documentation expectations prior to conducting visits

• Provided care for patients on all units at neurological rehabilitation hospital (acute, chronic, behavioral, lock-down behavioral).
• Supervised nursing staff and behavioral unit staff as hospital charge nurse including appropriate application of behavioral techniques to ensure patient and staff safety.

• Care of high-complexity patients in the academic inpatient setting in the medical/surgical oncology unit.
• First exposure to clinical research following various cooperative group protocols and industry protocols.
• Training and preceptorship of new graduate nurses