NewPhysical Therapist -Clinic Director JAG Physical TherapyPhysical Therapist -Clinic DirectorNew Brunswick, NJJAG Physical Therapy, a comprehensive outpatient, orthopedic physical therapy company with 100 facilities throughout Pennsylvania, New Jersey, and New York, is seeking compassionate and motivated individuals to join our winning team! Important Disclaimer Notice: The above statements are only intended to represent the essential job functions and general nature of the work being performed and are not exhaustive of the tasks that an Employee may be required to perform.
NewDirector of Mechanical Engineering PE JobotDirector of Mechanical Engineering PENew York, NY$200,000–$225,000 / yearLead feasibility studies, conceptual development, and detailed engineering for: Central utility plants, Steam generation & distribution systems, Chilled & condenser water systems, Heating hot water & hydronic systems, Thermal energy storage solutions, Combined Heat & Power (CHP), and microgrid applications. This position is best suited for a senior engineering professional with extensive experience in mechanical and energy systems, as well as a strong track record managing multidisciplinary teams and delivering high-impact projects within the New York market and beyond.
NewDirector of Workforce Development Global Kids IncDirector of Workforce DevelopmentNew York, NY$80,000–$85,000 / yearFull timeAdditionally, in collaboration with the Senior Director of Academic Programs and Quality Assurance, the Director of Workforce Development will plan workforce development strategies and goals to improve and ensure the successful integration of workforce programs across all school-based sites. The Director of Workforce Development will work in collaboration with the Senior Director of Academic Programs and Quality Assurance and the Director of Student Success to plan and integrate workforce development strategies and goals into our community schools and college & career readiness work.
Director, Technology Risk and Business Continuity United Nations Federal Credit UnionDirector, Technology Risk and Business ContinuityNew York, NY$150,000 / yearFull timeBachelor's degree in Risk Management, Information Systems, or related field• 10+ years of experience in a financial services environment with exposure to regulated environments, including a minimum of 4 or more years in a second line or commensurate risk function• Experience in technology, cyber, and operational resilience risk management, including regulatory compliance, risk identification, monitoring, issue management, risk reporting, and cross-functional collaboration with business partners. Partner with technology and business leaders within the three lines of defense framework to provide independent oversight and advisory support, ensuring technology risks are effectively managed and aligned with the organization's risk appetite, regulatory expectations, and strategic objectives.
NewDirector of Marketing JobotDirector of MarketingHoboken, NJ$180,000–$250,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Here's the highlight reel: Develop and execute omnichannel brand strategy — identifying where to play and how to win across retail, digital, and HCP channels.
NewDirector of Nursing (DON) Glens Falls CenterDirector of Nursing (DON)Brooklyn, NY$120,000–$140,000We also offer Daily Pay through a trusted third-party provider, giving you faster access to your earnings, as well as premium health coverage through Aetna with low out-of-pocket costs. About Us: Glens Falls Center is a 120-bed rehabilitation and skilled nursing facility located in Glens Falls, NY.
NewAssistant Director of Nursing (ADON) Bushwick CenterAssistant Director of Nursing (ADON)Brooklyn, NY$120,000–$130,000Bushwick Center for Rehabilitation and Healthcare is a 225-bed rehabilitation and skilled nursing facility located on the border of Brooklyn & Queens. Our staff is committed to ensuring the highest quality of life of all our residents, by maintaining each resident’s dignity and independence.
NewAssistant Director of Nursing (ADON) Skilled Nursing of BrooklynAssistant Director of Nursing (ADON)Brooklyn, NY$55A Skilled Nursing Facility in Brooklyn, NY is looking to hire an Assistant Director of Nursing (ADON) . Assist the Director of Nursing Services (DNS) with management responsibilities and maintaining quality of care.
Assistant Director of Nursing (ADON) Skilled Nursing of BronxAssistant Director of Nursing (ADON)The Bronx, NY$130,000Skilled Nursing of Bronx is hiring a Assistant Director of Nursing (ADON) in Bronx, NY. DUTIES: Assist the DNS with management responsibilities and in maintaining the quality of care.
Assistant Director of Nursing (ADON Beth Abraham CenterAssistant Director of Nursing (ADONThe Bronx, NY$130,000–$140,000A vital part of the Bronx community, the facility has a long history of providing a warm and nurturing environment, allowing each resident to get stronger, healthier, and happier. Beth Abraham Center for Rehabilitation and Nursing is a 448-bed rehabilitation and skilled nursing facility with impressive Resident and family satisfaction ratings.
Associate Medical Director Mitchell MartinAssociate Medical DirectorNew York, NY$225,000–$240,000 / yearBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. Associate Medical Director - New York, NY (Onsite) - Full Time - Mon-Fri 09:00am-05:00pm - $225,000-$240,000 Per Year.
NewInterim Director of Facilities and Operations Perennial ResourcesInterim Director of Facilities and OperationsStaten Island, NY$40–$45 / hourTemporaryFull timeDirector, Campus Administration, this senior staff role manages daily facilities services including HVAC, facilities maintainers, housekeeping, and security teams, preventive maintenance programs, as well as serving as the organizational lead for occupational health & safety and emergency response. Non-profit firm seeks a seasoned interim facilities leader to oversee campus-wide operations, maintenance, and strategic planning for buildings, grounds, and infrastructure.
NewManager / Director Transaction Services (M&A) Kforce Inc.Manager / Director Transaction Services (M&A)New York, NY$125,000–$200,000Run multiple and challenging Transaction Advisory Services engagements (financial due diligence), participating in transactions related to the acquisitions by private equity investor groups and strategic corporate buyers. Responsibilities Include: Manager/Director Transaction Services will lead buy - side diligence, sell - side diligence, working capital assistance, merger integration and optimization, divestitures and carve outs, and valuation services.
Director FP&A - Hospitality Kforce Inc.Director FP&A - HospitalityNew York, NY$160,000–$190,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
NewDirector of QM, Hospice & Palliative Care MJHSDirector of QM, Hospice & Palliative CareFort Lee, NJMaintains knowledge of current trends and developments in areas of responsibility through membership in appropriate professional organizations, attend in services and continuing education to maintain current knowledge and expertise, maintain up to date knowledge of the laws regulation and payor requirements that affect policy and procedure. Ensures the consistent development, implementation and accountability of performance improvement initiatives to enhance processes that support the provision of high-quality care and ensures effectiveness of performance improvement projects.
NewClinical Director/Physical Therapist - Cross Bronx Access Physical Therapy & WellnessClinical Director/Physical Therapist - Cross BronxBronx, NY$124,800–$135,200Founded in 2003 by brothers Chris and Steve Albanese and their wives, all practicing physical therapists, ACCESS PT was born out of a shared passion for delivering patient-centered care in their hometown of Orange County, NY. With a strong focus on partnership, exceptional service, and a culture of compassion, ACCESS PT continues to expand—driven by the vision of improving the lives of 100,000 patients annually.
NewAssistant Director of Nursing Care-OneAssistant Director of NursingTeaneck, NJ$114,000–$145,000 / yearAlong with the Director of Nursing, promote positive employee relations, strong customer service ethic and commitment to ongoing staff education and training, May exercise direction over the department in the absence of the Director of Nursing. Assist the Director of Nursing with regulatory compliance and ensure effective communication strategies with all levels of nursing staff to promote effective care delivery.
NewCase Management Director Encompass Health Rehabilitation Hospital of MechanicsburgCase Management DirectorColonial Park, PAJoin us in this journey of care, compassion, and leadership as we work together to make a difference where it matters most, serving as a key member of our leadership team overseeing the day-to-day operations and management of our Case Management department. - Oversee the interdisciplinary plan of care and the discharge planning process to ensure the effectiveness and appropriateness of services with a central focus on census management, patient care outcomes, and key care indicators.
NewHealth Services Director, RN Brightview Senior Living, LLCHealth Services Director, RNParamus, NJ$120,000–$130,000After the community opens, you will get to provide ongoing nursing assessments and care oversight, identify clinical trends, implement corrective action and monitor the accurate delivery of medications to our residents, in addition to working with the residents’ physicians and medical personnel on the best plan of action for their continued care. About Us: Overview: The Health Services Director, Registered Nurse at Brightview Senior Living exemplifies the vision, the mission, and the vibrancy of the organization and leads the delivery of exceptional clinical care to our residents.
NewSite Director at Midland KinderCare EducationSite Director at MidlandParamus, NJ$21.55–$30.20When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
Vice President / Director, Credit Analyst (Mortgage Sector) AxelonVice President / Director, Credit Analyst (Mortgage Sector)New York, NY$65–$72 / hourServe as a technical subject-matter expert on agency residential and commercial MBS, TBA, CMO, and DUS products for the Institutional Credit Analyst Team, Sales, and Trading teams. Collaborate with internal stakeholders, including coverage bankers, business lines, and risk teams, to provide credit expertise and support.
Fiduciary Director ECLAROFiduciary DirectorNew York, NYResponsibilities: Manage and develop trust centers, associated support, and specialty teams within Information, Management and Technology in roles with focus on delivering moderate complexity and risk. Required Skills: 8+ years of Fiduciary Products experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education.
NewDirector, Project Management & Business Excellence, CSPV Daiichi Sankyo, Inc.Director, Project Management & Business Excellence, CSPVBasking Ridge, NJ$193,040–$289,560 / yearFull timeChampions adoption of project management best practices and continuous improvement to strengthen CSPV operational excellence Business Excellence: Leads the development and implementation of operational excellence strategies in partnership with CSPV Leadership, aligning initiatives to business priorities and long-term goals. Leads and clearly articulates impact assessments of project outcomes—translating implications into actionable insights—while partnering with SMEs and leadership to shape implementation strategies and accelerate adoption.
Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Director, Clinical Safety ScientistBasking Ridge, NJ$201,840–$302,760 / yearFull timeRisk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Development - Hematology Daiichi Sankyo, Inc.Senior Director, Clinical Development - HematologyBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$280,350–$467,250 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
Associate Director, Regulatory (RIM) Business Systems and Operations Daiichi Sankyo, Inc.Associate Director, Regulatory (RIM) Business Systems and OperationsBasking Ridge, NJ$157,920–$236,880 / yearFull timeThe Associate Director, Business Systems & Operations Management will function at various times as a manager of one or more business systems, as a leader of sub-teams or workstreams within larger projects or programs, as a contributor within various systems-related working groups, and as a senior business analyst, as required. The Associate Director, Business Systems & Operations Management is responsible for managing the operational, administrative, and tactical support of assigned business systems; as well as contributing to projects and initiatives that optimize the use of information technology to achieve departmental, divisional, and enterprise business objectives.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
NewDirector, Global Oncology Medical Affairs, Scientific Partnerships Daiichi Sankyo, Inc.Director, Global Oncology Medical Affairs, Scientific PartnershipsBasking Ridge, NJ$201,840–$302,760 / yearFull timeLead the strategic identification, prioritization, and management of Cooperative Groups, academic networks, and external scientific partnerships; act as the primary medical interface to advance high-priority collaborations. The role will also establish and operationalize the infrastructure, processes, and collaboration frameworks required to support joint research and educational initiatives with Cooperative Groups, Academic Research Organizations and other research networks.
NewAssociate Director, Data Quality & Integrity, Global R&D & PV QA Daiichi Sankyo, Inc.Associate Director, Data Quality & Integrity, Global R&D & PV QABasking Ridge, NJ$153,600–$230,400 / yearFull timeLeadership & Strategy Execution – Lead execution of key elements of the global Data Integrity strategy and ensure alignment across R&D, PV, and MA.Translate strategic objectives into multi‑year roadmaps and annual operating plans for data integrity and computerized systems oversight (business operational data focus).Serve as a senior subject matter expert for data integrity and GxP computerized systems governance, advising leadership on risk‑based prioritization and compliance posture. This role leads cross‑functional initiatives, establishes program‑level oversight frameworks, mentors and develops QA capability, and partners with senior stakeholders to ensure robust data governance, regulatory compliance, and measurable continuous improvement.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
NewLicensed Social Worker Assistant Director Care-OneLicensed Social Worker Assistant DirectorBound Brook, NJ$52,000–$72,000 / yearSocial Service functions include but are not limited to: supervising social service staff, direct services, advocacy, counseling, service coordination, education, in-servicing, policy and program development and community relations. Provide for therapeutic intervention to help residents cope with the social and psychological aspects of their illnesses, impairments, or disabilities as well as their feelings about institutionalization and separation from family, community, physical and emotional loss.
NewAssistant Director of Social Services Care-OneAssistant Director of Social ServicesMorristown, NJ$53,000–$70,000 / yearSocial Service functions include but are not limited to: supervising social service staff, direct services, advocacy, counseling, service coordination, education, in-servicing, policy and program development and community relations. Provide for therapeutic intervention to help residents cope with the social and psychological aspects of their illnesses, impairments, or disabilities as well as their feelings about institutionalization and separation from family, community, physical and emotional loss.
NewAssociate Director - Quality Management (LSM) Becton DickinsonAssociate Director - Quality Management (LSM)Franklin Lakes, NJ$183,800–$294,100 / yearBuild an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose, initiate, and implement new processes and technologies to optimize efficiencies. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
Associate Director, Medical Writing - Publications JouléAssociate Director, Medical Writing - PublicationsRaritan, NJRemote$160,000–$165,000 / yearProvide expert writing and editing support to ensure timely production of high-quality documents (abstracts, posters, slide presentations, manuscripts, letters to editor, etc.) for publication in medical/scientific journals or presentation at meetings. A PhD, MD, or PharmD with a minimum of 5 years of relevant pharmaceutical/scientific experience is required OR a Master’s (or other advanced degree) with a minimum of 8 years relevant pharmaceutical/scientific experience is required.
Associate Director Corporate Communications JouléAssociate Director Corporate CommunicationsParsippany, NJ$135,000–$170,000 / yearJoin a growing biopharmaceutical organization where communications plays a critical role in shaping corporate reputation, supporting key business milestones, and translating complex science into meaningful stories. This is an opportunity to work closely with executive leadership and cross-functional teams to drive both external and internal communications initiatives across a fast-paced, highly visible environment.
Medical Science Director Northern CA JouléMedical Science Director Northern CAParsippany, NJRemote$200,000–$235,000 / yearServe as a scientific resource to healthcare providers, key opinion leaders, pharmacy stakeholders, and institutional decision-makers across inpatient and outpatient healthcare settings. Support medical affairs activities across oncology, infectious disease, nephrology, acute care, and related therapeutic areas through compliant scientific exchange, insight gathering, and collaboration.
Medical Science Director (Mid-Atlantic Region) JouléMedical Science Director (Mid-Atlantic Region)Parsippany, NJRemote$200,000–$240,000 / yearThis role serves as a clinical and scientific resource, facilitating evidence-based discussions, gathering medical insights, supporting clinical research initiatives, and collaborating cross-functionally to help inform medical strategy, education, and patient care. The Medical Science Director is a field-based medical affairs professional responsible for building scientific relationships with healthcare providers, key opinion leaders, and healthcare systems across oncology and related specialty therapeutic areas.
Medical Science Director (Ohio Valley) JouléMedical Science Director (Ohio Valley)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
Medical Science Director (New England Region) JouléMedical Science Director (New England Region)Parsippany, NJRemote$200,000–$235,000 / yearA field-based Medical Science Director will support Medical Affairs through compliant scientific exchange, insight gathering, and cross-functional collaboration across oncology and related therapeutic areas (infectious disease, nephrology, acute/critical care). This role partners with HCPs/KOLs, pharmacy leaders, and institutional stakeholders across inpatient/outpatient settings to support medical strategy, evidence generation initiatives, and scientific engagement (congresses, advisory boards, education).
Medical Science Director Southern CA JouléMedical Science Director Southern CAParsippany, NJRemote$200,000–$235,000 / yearServe as a scientific resource to healthcare providers (HCPs), key opinion leaders (KOLs), pharmacy stakeholders, and institutional decision-makers across inpatient and outpatient healthcare settings. Support medical affairs activities across oncology, infectious disease, nephrology, acute care, and related therapeutic areas through compliant scientific exchange, insight gathering, and cross-functional collaboration.
Director Medical Monitor JouléDirector Medical MonitorParsippany, NJ$210,000–$335,000 / yearServe as the primary medical contact for investigators and study sites regarding protocol-related medical questions, including subject eligibility and enrollment guidance. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Associate Director Access & Reimbursement CSL SeqirusAssociate Director Access & ReimbursementSummit, NJ$210,000–$250,000Convinces internal and external stakeholders about the value of the CSL Seqirus Customer Experience vision; Acts as the voice of the customer with internal stakeholders to build Seqirus’ acumen on customer challenges; Develops and executes business solutions at customers that help enhance CSL Seqirus’ partnership within CSL Seqirus primary channels. With relationship depth and breadth of customer interaction at various (senior management clinical / financial / operational) levels of the customer’s organization, builds and maintains relationships with key individuals to enable market access of CSL Seqirus vaccines, developing a favorable environment for pull-through at the national, regional, and local provider levels.
RN Team Director Hospice AccentCare, Inc.RN Team Director HospiceOssining, NY$100,000–$115,000Collaborate with program site leadership memebrs to monitor, manage, and mentor staff in patient care activities, productivity, and documentation per related policies and protocols. We’re proud to be named one of America’s Greatest Workplaces 2025 by Newsweek — a reflection of our shared commitment to excellence, integrity and compassion as we shape the future of aging in place.
NewAssociate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead within Hematology, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
Director, Risk Based Quality Management (RBQM) Daiichi Sankyo, Inc.Director, Risk Based Quality Management (RBQM)Basking Ridge, NJ$201,840–$302,760 / yearFull timeOversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness. Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
Director, Early Phase Biostatistics Daiichi Sankyo, Inc.Director, Early Phase BiostatisticsBasking Ridge, NJ$201,840–$302,760 / yearFull timeMentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR). Drug Development Strategy: Provides input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies’ requirements for countries and regions the drug is to be submitted.
Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$175,440–$263,160 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Associate Director PV Quality, Americas Daiichi Sankyo, Inc.Associate Director PV Quality, AmericasBasking Ridge, NJ$153,600–$230,400 / yearFull timeProvide operational QA leadership for the respective CSPV teams, including Quality Oversight for the Quality Plan execution, review of key CSPV regulatory documents, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective CSPV functional areas. Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.