Senior Manager, Clinical Risk Management Job at iconplc (Blue Bell)

Senior Manager, Clinical Operations/ Senior Global Trial Manager - FSP

Parexel are currently recruiting for an experienced Global Study Operations Mana...

Location

Italy; United Kingdom , Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 7 years of relevant clinical trial management experience
Global trial management experience is essential
Experience managing CRO outsourced studies is essential
Excellent leadership, communication, and organizational skills
Able to multi-task under limited direction and on own initiative
M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
Prior and demonstrable experience working at a senior level within Study start up preferred

Job Responsibility

Accountable for the end-to-end clinical trial delivery
Providing operational leadership and oversight of cross-functional deliverables
Leading a cross functional trial team to build and deliver the trial operational plan
Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution
Accountable for overall trial delivery, budget, timelines, quality, and milestones
Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
Identify risks and ensure mitigations and contingencies are being initiated and followed through
Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits

Director of Clinical Risk Management

The Director of Clinical Risk Management provides leadership and oversight of al...

Location

United States , Norfolk

Salary:

Not provided

Old Dominion University

Expiration Date

Until further notice

Requirements

Expert-level understanding of clinical care processes, standards of care, patient safety science (human factors, high-reliability principles, just culture), diagnostic error, communication failures, transitions of care, medication safety, informed consent, documentation standards, and event prevention
Ability to provide authoritative, real-time clinical risk guidance to physicians, APPs, nursing, and leadership during active events—balancing patient safety, ethical obligations, and liability exposure across diverse ambulatory and procedural settings
Demonstrated knowledge of specialty-driven risk patterns and controls for OB/GYN, Surgery & Procedural Practices, Radiation Oncology, Psychiatry & Behavioral Sciences, Family & Community Medicine / PM&R
Advanced working knowledge of federal and state healthcare requirements and risk implications
Ability to partner with counsel to interpret requirements, set defensible clinical risk positions, and embed compliance into operational workflows
Strong knowledge of professional liability/medical malpractice concepts
Ability to oversee investigations with a “claims-ready” approach while prioritizing patient safety improvements
Deep familiarity with ambulatory and academic medical group operations, quality structures, credentialing/privileging concepts, interdepartmental workflows, emergency response pathways, patient grievances, and risk controls across clinical sites
High proficiency with RMIS platforms and comfort leveraging EMR data
Advanced understanding of healthcare contracting risk

Job Responsibility

Provides leadership and oversight of all clinical and operational risk management functions for the Elmer and Joan Brock Virginia Health Sciences at ODU (VHS), the EVMS Medical Group, and affiliated healthcare entities
Assists in implementing and managing a comprehensive enterprise risk management (ERM) framework that integrates clinical, operational, financial, and reputational risk strategies across academic and clinical environments
Ensures healthcare-related risks are proactively identified, assessed, and mitigated
Maintains compliance with accreditation and regulatory standards
Promotes a culture of patient safety and institutional accountability

Fulltime

Senior Manager Clinical Operations and Strategic Alliances

The Sr. Manager, Clinical Operations and Strategic Alliances reporting to the Di...

Location

United States , Pleasanton

Salary:

173100.00 - 234100.00 USD / Year

10x Genomics

Expiration Date

Until further notice

Requirements

An Advanced degree (M.S., PharmD, Ph.D., M.B.A.) in a Life Science, Clinical, or related field is required
8+ years of relevant industry experience with 4-5 years of experience in Clinical Operations and Alliance / Program Management within the diagnostics, biotechnology, or pharmaceutical industry
Direct experience managing research studies involving large numbers of patient samples and complex molecular testing or biomarkers
Deep understanding of clinical study execution, site management, and the complexities of clinical sample logistics and chain of custody
Direct experience in managing high-value strategic alliances and driving value through the successful execution of collaborative research, development, or commercialization agreements
Demonstrated ability to manage competing priorities, swiftly resolve complex operational problems, and drive tangible results

Job Responsibility

Study Execution: Manage the operational execution of large-scale, longitudinal clinical research studies according to established agreements with academic institutions
Timeline & Risk Management: Own and drive clinical research study timelines, deliverables, and operational plans ensuring adherence to sampling schedules
identify operational risks regarding enrollment, setup, or logistics early, implementing mitigation strategies to maintain study integrity
Sample Logistics & Chain of Custody: Establish and enforce auditable procedures for sample collection, tracking, and chain of custody, ensuring compliant transport from clinical sites to 10x Genomics laboratory
Budget & Resource Oversight: Manage the study budgets, including the oversight of reimbursement, equipment provisioning, and consumables provided to partner sites
Regulatory & Quality Compliance: Ensure all study activities comply with IRB protocols, patient consent requirements, and GCLP/CLIA standards where applicable
Partnership Management: Manage a diverse, high-value portfolio of academic collaborations and strategic partnerships to ensure all projects and agreements track toward established milestones and outcomes
Governance Management: Ensure transparent communication, effective decision-making, and rapid conflict resolution between internal teams and external partners
lead and facilitate Joint Steering Committees (JSCs) and cross-functional governance meetings as needed
Stakeholder Management: Act as the primary liaison between internal teams and key stakeholders at relevant academic institutions and industry partners to foster strong, collaborative relationships that drive engagement and performance

What we offer

Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Generous time off
Competitive and comprehensive health benefits package
Easy-to-use benefits that promote wellbeing and make your life easier
Family friendly policies like parental leave
Award-Winning Workplace

Fulltime

Clinical Risk Manager

The Clinical Risk Management Department supports and furthers the organization's...

Location

United States , Olathe

Salary:

Not provided

The University of Kansas Health System

Expiration Date

Until further notice

Requirements

Bachelors Degree in Nursing from an accredited college or university
5 or more years of experience as a nurse in a healthcare setting
2 or more years of management experience or leadership role in a healthcare setting
2 or more years of experience in one or more of the following areas: risk management, quality improvement, health information management, healthcare administration, business administration, legal support, or insurance claims investigation, and settlement
Licensed Registered Nurse (LRN) - Single State - State Board of Nursing

Job Responsibility

Participate in day-to-day risk management operations, including risk mitigation, investigations, and responding to safety events
Develops, coordinates, and administers facility-wide systems for risk identification, investigation, and risk reduction
Reviews collected data to identify trends regarding accidents or occurrences, and recommends corrective action to management
Informs leaders of events/incidents, issues, findings, and risk management recommendations
Proactive analysis of patient safety and medical errors processes
Prepares reports for leaders regarding trends/patterns and findings
Exercise professional judgment and critical thinking to facilitate focused investigation and root cause analysis and the development of appropriate corrective action plans
Leads investigations for adverse events and sentinel events
Prepares risk management and patient safety reports to be submitted to the senior leadership, board, and other appropriate committees
Active participation in patient safety activities by providing data to support priorities, clinical risk management expertise, and participating in patient safety projects

Fulltime

Senior Clinical Trial Manager

Sr Local Trial Manager – Solid Tumor Oncology - Home Based (US). ICON plc is a w...

Location

United States , Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BA/BS degree
Degree in a health or science related field
3 - 5+ years of trial end to end management experience
Start-up & Database Locks/Cleaning experience preferred
Solid Tumor Oncology experience required
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
Strong IT skills in appropriate software and company systems
Willingness to travel with occasional overnight stay away from home according to business needs
Proficient in speaking and writing the country language and English
Good written and oral communication skills as appropriate

Job Responsibility

Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution
Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams
Manages and oversees Central IRB and other local vendors including set up of vendor purchase orders, invoice review and approval, and change-orders
Execution of local milestones from feasibility through study close out
Resourcing of country-level roles, including support with transitions
Inspection Readiness and AQR at the country level
Close collaboration with assigned Local Trial Managers (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs)
Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL)
Country level ad hoc meetings during any phase of the study
Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Senior Clinical Site Manager

Senior Clinical Site Manager (SCRA) – Home-Based | Adelaide or Melbourne | Rare ...

Location

Australia , Melbourne

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Experience as a CRA II or Senior CRA within a CRO, biotech, or pharmaceutical environment
Strong site-facing experience with proven ability to build and maintain relationships
Excellent problem-solving skills and ability to think creatively to overcome recruitment challenges
High attention to detail with experience reviewing data and identifying site issues
Outstanding communication skills with the ability to adapt style across different audiences
Solid knowledge of ICH-GCP and clinical trial processes
Ability to work independently in a fast-paced, global environment

Job Responsibility

Build, develop, and maintain strong relationships with investigators and site staff
Lead all aspects of site management, including selection, initiation, monitoring, and close-out visits
Identify site performance trends and proactively address recruitment or operational challenges
Review data and site metrics to identify risks and implement solutions
Act as the primary point of contact for study sites
Support study delivery through collaboration with Project Managers, vendors, and internal teams
Contribute to study start-up activities, documentation, and regulatory submissions
Ensure studies remain audit and inspection ready at all times
Drive innovative approaches to improve site engagement and patient recruitment

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Parttime

Senior Manager, Inspection Management

Location

United States , Cambridge

Salary:

130800.00 - 209400.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

BS/BA, MS or PhD and a minimum of 10, 8, 6 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.
Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.
Experience with inspection coordination and logistical planning for regulatory authority inspections.
Experience with work in the Regulatory Intelligence area.
Experience developing responses to regulatory authority inspection findings.
Experience working with CROs, vendors, and relationship management.
Leadership skills with ability to effectively organize and execute tasks
Ability to interact effectively with all levels within the organization.
Ability to work both independently and in a team environment.

Job Responsibility

Build and maintain strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.
Maintain in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.
Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.
Coordinate and manage inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.
Provide guidance and direction in development of responses to observations resulting from inspections of Moderna’s R&D programs.
Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.
Lead and manage post-inspection lesson’s learned sessions, ensuring all actions are tracked to completion.
Contribute to and maintain inspection management plans, trainings, and strategies for the R&D Quality inspection management program.
Review and provide input into study team inspection preparation activities, storyboards, etc.
Collaborate with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

Senior Clinical Trial Manager

The Sr. Clinical Trial Manager (CTM) is responsible for supporting or leading th...

Location

United States , Madison

Salary:

91000.00 - 155000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in the life sciences or field as outlined in the essential duties
5+ years of experience in clinical research
1+ year of experience of experience leading project teams through the start-up, study conduct, data management, analysis, close out and report writing of clinical studies
Clinical monitoring experience including data review, query resolution, protocol deviation identification/tracking/trending, site initiation, site maintenance, and site closeout visits
Experience writing, reviewing and editing protocols
Knowledge of applicable quality standards (e.g. Good Clinical Practices (ICH/GCP), ISO 20916) and applicable local and national regulations governing clinical research
Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Experience providing oversight to external vendors (e.g. CRO, central labs, call centers, DCT providers)

Job Responsibility

Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities
Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents
Develop plans for systems and materials required to support the efficient execution of clinical studies
Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances
Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT)
Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting
Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites
Develop study budgets and is responsible for accurately forecasting and managing study expenses
Oversee site contracting and study budget management
Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
A retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

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Senior Manager, Clinical Risk Management

Job Description

Job Responsibility

Requirements

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