International super-network of clinical research sites conducting Phase 1 through Phase IV trials across all therapeutic areas

Advisory consultant for all Clinical Operations, including key Clinical, activities.

Provide strategic direction across all therapeutic areas and other divisions across PPD to ensure a customized BIOTECH delivery model effective each client within portfolio. Overall accountability for partnership with designated leads for delivery across the BIOTECH portfolio through consultation with and leadership to program delivery, business development, and operational leads.

Leading Clinical Operations within CNS TA for a biotech advancing research in biologics and gene therapy.

Running global clinical trials for Vertex Pharmaceuticals through PRA Health Sciences Embedded Solutions.

Responsible for leading and directing Beacon Hill Pharma in the PA/NJ/NY area, as well as managing national accounts. Applies nearly 20 years of clinical research and project management experience, education, and training to the art of partnering exceptional professionals with dynamic companies in the life sciences industry. The ability to work cross-functionally and her natural inclination to solve problems through root cause analysis enables service to clients by establishing relationships based on empathic perception. Personal experience working in the life sciences industry for and with pharmaceutical, biotech, device, and diagnostic sponsors and vendors across all phases and within a vast array of therapeutic areas provides a unique service to life science companies that fosters a true understanding of each client’s corporate culture, industry challenges, business models, and growth potential. Specialties: Core clinical functional areas --- Medical, Clinical, Project Management Data Management, Biometrics, Drug Safety, Medical Writing, Regulatory Affairs, Quality Control & Assurance, Document Management, Medical Affairs, Programming, Monitoring --- up to and including Executive Management.

Developed the Clinical Solutions division: implemented, managed, and socialized PM and clinical research development disciplines and operational processes; created business model, including all SOPS, all working documents, all business development material, etc.; developed sales/BD training program. Applied clinical expertise to assess clients’ requisitions and potential risks, identify opportunities for efficiencies, facilitate systemic metric reporting, ensure compliance, and support adherence to quality, cost, and timeline(s), Created and chaired the Clinical Solutions Management Team to drive operational and business development strategies, and to manage resource productivity and commitment to quality by providing oversight and risk mitigation procedures. Approved all new business; developed and finalized all contracts, including but not limited to MSA, SOW, pricing, RACI, and deliverables. Reported directly to VP, Technical & Professional Services to ensure infrastructure, processes, and resources optimally support all business requirements.

Report directly to VP of Operations, followed by President/CEO, serving as Project Manager on multiple expert committee and/or clinical trial projects, and acting as first line of communication between company and clients. Lead internal process improvements, implementation, and training. Author/co-author SOPs. Support proposal development by providing resource and protocol-specific sections to proposal text and specification as needed for budget development. Participate and/or lead RFP responses and bid defenses. Lead and/or participate in departmental initiatives, and provide regular status reports to upper management.

Manage clinical trials for sponsor (pharmaceutical) company in an FSP model. Phase I global and domestic trials. Manage programming, data management, medical writing, clinical, biostatistical, and operations work streams within a highly matrix structure to deliver projects to meet time, quality and cost parameters. Create and deliver compound, indication, and protocol training. Identify revise, and execute processes to meat clients' goals.

Manage US and global clinical trials, Phase I through Phase IV, in various therapeutic areas. Provide compound, indication, and protocol training to staff. Responsible for delivery and execution of multiple domestic & international clinical studies within overall program timeline, cost and quality metrics, reporting progress, risks and mitigations to upper management and stakeholders. Lead and manage study deliverables through internal and external resources; primary point of contact and interface across functional groups (programming, data management, biostats, site management, operations, clinical, medical writing), vendors, and clients. Work directly with Marketing and Commercial colleagues to align promotional, sales, and clinical objectives.

Manage domestic and global clinical research trials for Pfizer in various Phases and therapeutic areas in an FSP model. Phase I global and domestic trials. Oversee programming, data management, medical writing, clinical, biostatistical, and operations work streams within a highly matrix structure to deliver projects to meet time, quality and cost parameters.

Oversee all projects and personnel for 3 services: Protocol Feasibility, Site Feasibility, Secure Document Exchange. Work with BD, Sales, Contracts/Proposals, Programming, QC, and Operations to ensure on-time delivery of quality products and services. Interview, select, and supervise department staff through performance evaluations and performance management. Develop corporate processes for management of timelines, resources, and projects, including SOPs.

Manage domestic and international clinical trials (various Phases and multiple therapeutic areas). Manage all study team personnel and lead all operational activities at a study and program level to progress time, cost, and quality deliverables. Contribute to steering committees, submission and regulatory defense teams, and Advisory Boards. Liaise with Sr. Directors to support competency development through mentoring and training, and help develop and implement operational best practices. Select and manage external service providers, while facilitating strong partnerships. Provide operational expertise to Sr. Directors for protocol concept, recruitment strategies, and risk management.

Manage Clinical Trial Managers (10 direct reports) including performance management/evaluations, career management, salary increase and bonus recommendations, and project support to direct reports. Report to upper management progress and issues of the program or of personnel, and present risk management strategies and timeline controls. Work closely with Clinical Program Team Leader (medical), Medical Monitor, and data management to ensure proper and timely execution of study processes. Provide management and oversight to, and establish and maintain key interactions with, major customers (internal/external), vendors, and marketing companies. Manage global clinical trials across various functions in matrix infrastructure.

Manage domestic and international clinical trials (various Phases and multiple therapeutic areas). Manage all study team personnel and lead all operational activities at a study and program level to progress time, cost, and quality deliverables. Contribute to steering committees, submission and regulatory defense teams, and Advisory Boards. Liaise with Sr. Directors to support competency development through mentoring and training, and help develop and implement operational best practices. Select and manage external service providers, while facilitating strong partnerships. Provide operational expertise to Sr. Directors for protocol concept, recruitment strategies, and risk management.

Manage direct reports (15) for career development, performance management, and compensation. Provide critical chain management and report potential risks and risk management strategies to Sr. Directors, VPs, and to the client. Plan, organize, and manage all aspects of assigned clinical trial programs on behalf of the client. Organize and lead necessary team training efforts, and consult with regional management personnel to coordinate field training, communicate observations, implement modifications/corrections. Partner with Business Development to manage contract modifications and identify business opportunities.

Responsible for the overall budget and management of clinical research associates. Report financial and clinical study progress to upper management. Travel with and assess direct reports’ performance; provide subsequent re-training. Provide corporate, protocol, and therapeutic training to team.

Responsible for working with project managers to: manage clinical research associates and research assistants, complete performance appraisal and salary increase recommendations [10 direct reports]. Support study team to develop monitoring guidelines, lead query generation/resolution and data listings review, review/approve monitoring trip and expense reports, ensure ongoing team/protocol training, conduct co-monitoring/training site visits, review and manage budgets, and report findings to client.

Mentor Clinical Research Associates (CRAs) and Assistant CRAs. Develop study guidelines and review source documentation. Responsible for the conduct of multi-center clinical research studies. Provide project support to sponsor as contracted, to include: present at Investigator Meetings; assist in investigator recruitment; evaluate, initiate, monitor, and close out sites according to applicable SOPs, ICH/GCO guidelines, and FDA regulations; review database for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements.

Mentor CRAs. Collaborate with senior management on development and maintenance of clinical trials. Responsible for the conduct of multi-center clinical research studies. Provide project support to sponsor as contracted, to include: present at Investigator Meetings; assist in investigator recruitment; evaluate, initiate, monitor, and close out sites according to applicable SOPs, ICH/GCO guidelines, and FDA regulations; review database for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements.

Responsible for the conduct of multi-center clinical research studies. Provide project support to sponsor as contracted, to include: present at Investigator Meetings; assist in investigator recruitment; evaluate, initiate, monitor, and close out sites according to applicable SOPs, ICH/GCO guidelines, and FDA regulations; review database for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements.

Responsible for the conduct of multi-center clinical research studies. Provide project support to sponsor as contracted, to include: present at Investigator Meetings; assist in investigator recruitment; evaluate, initiate, monitor, and close out sites according to applicable SOPs, ICH/GCO guidelines, and FDA regulations; review database for completeness, clarity, legibility, conformity to available source documentation, and adherence to protocol requirements.

PROGRAM COORDINATOR: Develop treatment programs in accordance with State and Federal regulations; develop, implement, and supervise multi-level alcohol and drug abuse treatment programs in various cross-county treatment facilities; maintain quality assurance and databases for facility and State; serve as primary counselor. PRIMARY COUNSELOR: Provide individual and group counseling, education, and treatment. Assess clients for potential DSM diagnosis. Complete psychosocial assessment, diagnostic summary, treatment plans, progress notes, treatment plan updates, case consultations, comprehensive continuing care plan, and discharge summary. Conduct/provide family interviews, appropriate mental health, vocational, and domestic referrals, and conferences with employers and EAP personnel for back-to-work plans.

Provide individual and group counseling, education, and treatment. Serve on local school prevention committees, and provide in-service education to teachers and parents. Serve on multi-disciplinary treatment planning teams; assess clients for potential DSM diagnosis. Complete psychosocial assessment, diagnostic summary, treatment plans, progress notes, treatment plan updates, case consultations, comprehensive continuing care plan, and discharge summary. Conduct/provide family interviews, appropriate mental health, vocational, and domestic referrals, and conferences with employers and EAP personnel for back-to-work plans.