Director, Clinical Operations Job at iconplc (Sofia)

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Clinical Director Operations

Overseeing operational and strategic processes to achieve business goals, managi...

Location

Canada , New Brunswick

Salary:

Not provided

Foundever

Expiration Date

Until further notice

Requirements

Minimum 10 years telehealth clinical nursing experience
Minimum 3 years supervisory experience
Master’s Degree in Nursing or equivalent health designation
Registered and in good standing with the provincial/territorial nursing body legislated to license nurses in the jurisdiction in which you practice
Client Relationship Management - Demonstrated success in building excellent customer/client relationships
Fiscal Management – Sound financial management stills to achieve revenue targets and profitability goals
Patient Safety Advocacy - Knowledge of healthcare policies, procedures, quality management systems, training programs, clinical systems, and operational objectives focused on patient safety
Team Leadership & Performance Management – Proven ability to lead and develop teams, monitoring and delivering on key performance metrics, and driving performance through coaching and continuous feedback
Effective Communication & Conflict Resolution – Strong verbal and written communication skills with the ability to convey information clearly, handle escalations, and resolve issues with professionalism
Operational Efficiency & Problem-Solving – Strong ability to optimize workflows, manage escalations, and implement process improvements to enhance productivity and response times

Job Responsibility

Nurture client relationships by ensuring proactive delivery of solutions that enhance service quality and reduce costs
Foster a culture of patient safety through the development of policies, procedures, quality management, training, clinical systems and operational objectives
Oversee operating systems, policies and procedures within the Healthcare division for continual improvement aligned with business goals
Lead process improvement efforts within the vertical
Manages both human and material resources
Provide strong support for the long-term strategies of the organization
Instrumental in translating the company’s vision into actionable strategies
Collaborating with senior leadership, they help define long-term goals and develop comprehensive plans to achieve them
Supports Foundever and clients in achieving service, quality and contribution goals
Demonstrates sound fiscal management in achieving profitability goals

What we offer

Impactful work
Opportunity to work on cutting-edge AI technologies that will be game-changers for our business
Professional growth
Continuous learning and development opportunities in a dynamic, remote work environment
Competitive compensation
Attractive salary and benefits package
Collaborative environment
A supportive team culture with opportunities for occasional travel for training and industry events

Fulltime

Senior Site Director, Clinical Operations

Proclinical is seeking a Site Director, Clinical Operations to be responsible fo...

Location

Belgium , Brussels

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's Degree in a Life Science discipline required
Bachelor's Degree in Nursing or RN a plus
Proven working years of direct site monitoring experience required
Detailed understanding of all aspects of clinical site monitoring as well as understanding of overall drug development required
Thorough understanding of EMA, ICH and GCP guidelines and applicable local regulations
Excellent critical thinking skills and ability to understand complex patient histories, medical terminology and treatment landscapes
Ability to interpret study level metrics data and proactively identify and mitigate risks through study lifecycle
Detail-oriented, organized and committed to quality and consistency
Results-driven and capable of managing competing high-priority assignments with a proven track record of achieving deliverables within specified timelines
Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs

Job Responsibility

Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
Arrange for monitoring availability and ensure data entry timelines are maintained at assigned sites
Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
Develop and cultivate strong site relationships and ensure continuity of site relationships
Communicate with investigators and site staff on issues related to protocol conduct, recruitment, protocol deviations, inspection readiness and overall site performance
Identify, assess, escalate and resolve site performance or quality issues in a timely manner
Complete feasibility and site identification activities for new clinical studies
Conduct start-up and maintenance activities for designated sites including preparation and collection of essential documents required for regulatory and IRB/EC submission (initial and amendments)

Director Clinical Operations - Radiology

The Director, Radiology Clinical Operations, provides leadership and direction t...

Location

United States , Kansas City

Salary:

Not provided

The University of Kansas Health System

Expiration Date

Until further notice

Requirements

Master's Degree in related field of study from an accredited college or university
5 or more years of experience in Radiology or Imaging Services Leadership/Management
Fluent English - Must be able to read, write, understand, and speak English
Proficient in Quality Improvement Techniques and Lean methodologies
Commands advanced communication skills with various levels of professionals within multiple media/formats
Proficient with Microsoft Applications

Job Responsibility

Provides clinical direction and leadership to the Radiology Services
Directs clinical operations and integrates services within Radiology and with other departments
Directs and manages clinical oversight of all divisional depts
Creates effective work plans, which include identifying the correct resources, staffing, processes, and space needed by the work unit
Directs improvement work as process owner while guiding leaders and teams towards efficiency of work unit operations and use of resources
Sets the work unit's priorities in alignment with TUKHS priorities
Delegates authority and meets deadlines
Identifies needs of Radiology leaders and staff as well as customers to ensure priorities are aligned with the needs and priorities of Health system and other customers
Sets goals for each Radiology modality in collaboration with Sr. Director Radiology and Vice President Health professions
Ensures adequate resources are available to provide high quality care

Fulltime

Sr. Director, Clinical Operations

Join Enveda as a Sr. Director, Clinical Operations and help us transform natural...

Location

United States

Salary:

225000.00 - 275000.00 USD / Year

Enveda

Expiration Date

Until further notice

Requirements

A seasoned clinical operations leader with 12-15+ years of experience
Proven track record managing CROs and vendors in complex, multi-center, international studies
Strong working knowledge of ICH-GCP, FDA/EMA regulations

Job Responsibility

Lead the operational strategy and execution of IBD clinical development programs
Oversee an outsourced clinical operations model ensuring rigor, speed, and compliance
Collaborate with cross-functional teams to ensure operational feasibility and alignment
Build, mentor, and lead a high-performing Clinical Operations team and external partners

What we offer

90% Medical, Dental, Vision
401k Match
Flexible PTO
Adoption Assistance

Fulltime

Campus Associate Director Nursing, Clinical Operations

As an associate for a certified Great Place to Work, you will join a collaborati...

Location

United States , Los Angeles

Salary:

110256.35 - 159866.30 USD / Year

American Career College

Expiration Date

Until further notice

Requirements

Must have a minimum of three (3) years of experience as a registered nurse
one (1) year shall be in teaching or clinical supervision, or a combination thereof, in a state approved registered nursing, vocational or practical nursing, or psychiatric technician school within the last five (5) years
or a minimum of three (3) years of experience in nursing administration or nursing education within the last five (5) years.
Leadership knowledge in the program field to cultivate a learner-centered environment and to foster excellence.
Knowledge in technological support and delivery of program area and services.
Knowledge and evidence of strong supervisory and management skills as applicable to specialized program area.
Knowledge of state, federal and local laws/regulations relating to programs, governmental compliance and other regulatory standards such as Title IV, ABHES, BVNPT, BPPE, and other accreditation standards.
Hold a minimum of a baccalaureate degree in nursing or a related field from an academic institution accredited by a regional or national accrediting agency that is recognized by the US Secretary of Education or Council for Higher Education Accreditation (CHEA).
Must have completed a course or courses offered by an accredited school with instruction in administration, teaching, and curriculum development.
Current unencumbered California Registered Nurse (RN) License is required.

Job Responsibility

Overseeing and coordinating all clinical-related activities within the nursing program
Managing clinical instructors, cultivating and maintaining clinical partnerships, securing and scheduling clinical placements, overseeing clinical observations, required documentation and reporting, and ensuring compliance with college and accreditation standards
Supporting clinical faculty in meeting course objectives and ensures that students successfully complete clinical assignments while maintaining the integrity and quality of the clinical education experience

What we offer

medical
dental
vision
flexible spending accounts
401(k) match
paid time off
holidays
parental leave
tuition reimbursement
adoption assistance

Fulltime

Senior Director of Clinical Operations - sutacimig program

Hemab Therapeutics is seeking a Senior Director of Clinical Operations — a high-...

Location

United States , Boston

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor's degree or higher in life sciences, biology, or related field
Strong command of ICH/GCP and international regulatory requirements
15+ years of clinical operations/clinical program management experience in pharmaceutical or biotech
Experience in rare disease, hematology, or bleeding disorders preferred
10+ years in a management or functional leadership role
Demonstrated ability to identify and implement operational process improvements
Proven track record of on-time, on-budget trial delivery in complex global programs
Excellent cross-functional collaboration and executive communication skills
Deep expertise in early and late-phase trial design and execution
Experience managing and optimizing CRO and vendor relationships

Job Responsibility

Drive innovative, creative and efficient trial design and optimization
Accountability for trial start, recruitment, enrollment and end to end execution
Represent Clinical Operations on the Asset Team and Clinical Strategy Subteam, contributing strategic and operational input on the sutacimig clinical development plan
Own end-to-end operational execution of clinical trials from protocol finalization through clinical study report
ensuring delivery on time, within budget, and to the highest quality standards
Drive rigorous planning and accountability across all functions: define milestones, manage risks proactively, and resolve operational issues with urgency and precision
Build and evolve fit-for-purpose processes, standards, and operating procedures that scale with the organization and reflect industry best practice
Establish and maintain transparent, data-driven reporting mechanisms to keep executive leadership and cross-functional teams fully informed on trial status, risks, and performance metrics
Lead budget ownership across the program including forecasting, tracking, and actively managing spend to ensure financial discipline without compromising quality or speed
Proactively identify and implement process innovations including novel trial designs, technology platforms, and decentralized/hybrid trial elements to accelerate timelines and improve patient access

Fulltime

Senior Director of Clinical Operations - HMB-002 program

ABOUT THE ROLE Hemab Therapeutics is seeking a Senior Director of Clinical Oper...

Location

United States , Boston

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Bachelor's degree or higher in life sciences, biology, or related field
Strong command of ICH/GCP and international regulatory requirements
15+ years of clinical operations/clinical program management experience in pharmaceutical or biotech
10+ years in a management or functional leadership role
Demonstrated ability to identify and implement operational process improvements
Proven track record of on-time, on-budget trial delivery in complex global programs
Excellent cross-functional collaboration and executive communication skills
Deep expertise in early and late-phase trial design and execution
Experience managing and optimizing CRO and vendor relationships
Registration (BLA/MAA) submission experience

Fulltime

Associate Director, Regional Clinical Operations

Associate Director, Regional Clinical Operations. ICON plc is a world-leading he...

Location

United States , Atlanta; Houston; Tampa; Dallas

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum Bachelor’s degree with 5-7 years of experience in Clinical Trial Operations in pharmaceutical / biotechnology industry or Clinical Research Organization, or equivalent, including at least 3 years in a role of primary responsibility for clinical trial execution and management
Thorough understanding and experience in global clinical trials in a diverse range of patient populations with preferred experience in both oncology and hematology
Direct management experience and supervisory responsibility
Demonstrated leadership and management skills
Goal oriented, self-starter with proven ability to work independently
Good knowledge and experience working with external specialist vendors
Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel
Able to proactively identify issues and provide potential solutions for resolution
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines and to established quality standards
Proficient in Outlook/Word/Excel/PowerPoint

Job Responsibility

Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget
Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans
Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy
Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials)
Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies
Drives evidence-based site recommendations and selection
Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs
Align local and central initiatives and advise and guide on effective community engagement activities
Conduct co-monitoring and site identification visits, as needed
Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones

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

Fulltime

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Director, Clinical Operations

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