Global Clinical Delivery Manager Job at iconplc (Sofia)

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

Senior Program Manager, Global Clinical Training and Programming

Reporting to the Director of Clinical Training, the Senior Program Manager, Clin...

Location

Japan , Tokyo

Salary:

8964800.00 - 10309520.00 JPY / Year

Spring Health

Expiration Date

Until further notice

Requirements

Clinical license or equivalent in your country
3-5 years of experience in facilitation and event planning
Complete knowledge and understanding of the unique global challenges, potential solutions, and Clinical Training and Programming
Complete knowledge of Program Management and data evaluation
Complete knowledge of Google Suite, Zoom, and additional events platforms as needed
Solid understanding of instructional design and content development, including strong working knowledge of Adult Learning Principals
Knowledgeable about training evaluation techniques
Communicate effectively with customers and fellow Spring team members

Job Responsibility

Serve as the primary Project Manager for Global (Non US) Clinical Training and Programming
Serve as a SME on Global Clinical Training and Programming, including across time zones, cultures and languages
Develop and implement a Global Clinical Training and Programming strategy that is sustainable for continued growth
Coordinate logistics such as creating virtual events platforms, finding clinical providers, ensuring materials are prepared, tracking reporting and evaluation metrics
Work closely with large Jumbo customers to consult on Training and Programming planning, including partnering with internal stakeholders to consult, manage and advise customers
Work closely with the Global team regarding strategy and implementation
Partner with US Program Managers to plan and coordinate training and programming
Ensure we are measuring training and program effectiveness
If possible, involved in some delivery and/or producing of events
Will take a leadership role in planning for global programming related to events such as World Mental Health Day

Fulltime

Senior Program Manager, Global Clinical Training and Programming

Reporting to the Director of Clinical Training, the Senior Program Manager, Clin...

Location

Singapore

Salary:

125600.00 - 144440.00 SGD / Year

Spring Health

Expiration Date

Until further notice

Requirements

Clinical license or equivalent in your country
3-5 years of experience in facilitation and event planning
Complete knowledge and understanding of the unique global challenges, potential solutions, and Clinical Training and Programming
Complete knowledge of Program Management and data evaluation
Complete knowledge of Google Suite, Zoom, and additional events platforms as needed
Solid understanding of instructional design and content development, including strong working knowledge of Adult Learning Principals
Knowledgeable about training evaluation techniques
Communicate effectively with customers and fellow Spring team members

Job Responsibility

Serve as the primary Project Manager for Global (Non US) Clinical Training and Programming
Serve as a SME on Global Clinical Training and Programming, including across time zones, cultures and languages
Develop and implement a Global Clinical Training and Programming strategy that is sustainable for continued growth
Coordinate logistics such as creating virtual events platforms, finding clinical providers, ensuring materials are prepared, tracking reporting and evaluation metrics
Work closely with large Jumbo customers to consult on Training and Programming planning, including partnering with internal stakeholders to consult, manage and advise customers
Work closely with the Global team regarding strategy and implementation
Partner with US Program Managers to plan and coordinate training and programming
Ensure we are measuring training and program effectiveness
If possible, involved in some delivery and/or producing of events
Will take a leadership role in planning for global programming related to events such as World Mental Health Day

Fulltime

Senior Program Manager, Global Clinical Training and Programming

Reporting to the Director of Clinical Training, the Senior Program Manager, Clin...

Location

India , Mumbai

Salary:

2301600.00 - 2646840.00 INR / Year

Spring Health

Expiration Date

Until further notice

Requirements

Clinical license or equivalent in your country
3-5 years of experience in facilitation and event planning
Complete knowledge and understanding of the unique global challenges, potential solutions, and Clinical Training and Programming
Complete knowledge of Program Management and data evaluation
Complete knowledge of Google Suite, Zoom, and additional events platforms as needed
Solid understanding of instructional design and content development, including strong working knowledge of Adult Learning Principals
Knowledgeable about training evaluation techniques
Communicate effectively with customers and fellow Spring team members

Job Responsibility

Serve as the primary Project Manager for Global (Non US) Clinical Training and Programming
Serve as a SME on Global Clinical Training and Programming, including across time zones, cultures and languages
Develop and implement a Global Clinical Training and Programming strategy that is sustainable for continued growth
Coordinate logistics such as creating virtual events platforms, finding clinical providers, ensuring materials are prepared, tracking reporting and evaluation metrics
Work closely with large Jumbo customers to consult on Training and Programming planning, including partnering with internal stakeholders to consult, manage and advise customers
Work closely with the Global team regarding strategy and implementation
Partner with US Program Managers to plan and coordinate training and programming
Ensure we are measuring training and program effectiveness
If possible, involved in some delivery and/or producing of events
Will take a leadership role in planning for global programming related to events such as World Mental Health Day

Fulltime

Global Delivery Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or related field
advanced degree preferred
Minimum of 5 years of experience in clinical research
1-2 years working as an Associate Project Manager within a CRO or Pharma setting
Vendor management experience
Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards
Well familiar with key systems used in clinical trial delivery
Experience in using Trial Master File industry accepted standard
Strong project management skills (preferably with analytical / financial skills) and good leadership skills
Excellent verbal and written communication in English

Job Responsibility

Support the coordination and management of clinical trials
Contributing to the design, analysis, and advancement of innovative treatments and therapies
Delivering the clinical study to time, cost and quality
Ensuring inspection readiness by taking an oversight over study eTMF completeness
Working on end-to-end operational study delivery activities, from study setup to study archival
Setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP)
Working cross-functionally, with internal and external partners, on clinical study management activities
Monitoring study conduct and progress, identifying, resolving and escalating risks/issues
Reviewing key clinical documents, including the Protocol and Informed Consent Forms
Leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan etc.)

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
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Global Clinical Trial Leader - Sponsor Dedicated - Home Based

As a part of the global Project Leadership group at Parexel, you are responsible...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 5 years of relevant clinical trial management experience
Strong clinical trial project management experience
In depth understanding of project management with an emphasis on team work, to promote high performance teams
Experience in either Oncology, CNS, Immunology or Vaccines
Extensive experience in clinical trial project management across international trials
Masters Degree ideal but not essential

Job Responsibility

Accountable for the accurate planning and operational feasibility of trial timelines
and oversight of trial preparation to ensure trial team members are aligned and on track
Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
Verifies and provides input into the country allocation and oversees trial feasibility
Accountable for development and implementation of trial level engagement plans, recruitment planning and risk mitigation
Leads development of core trial and patient facing documents
Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements
compliance with SOPs and continuous risk monitoring/mitigation
In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting
Prepare and implement amendments of core documents, including training material updates/retraining as needed

Fulltime

Manager, Clinical Supply Chain

Proclinical is seeking a Manager, Clinical Supply Chain to oversee and execute c...

Location

United States , Cambridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific field, Supply Chain Management, or a related discipline
Hands-on experience in global clinical supply chain management, including packaging, labeling, inventory, and distribution
Strong understanding of clinical trial operations and the drug development lifecycle
Foundational knowledge of GMP, GxP, GCP, and global regulatory requirements (e.g., FDA, EU)
Proficiency with systems and tools such as IRT/IXRS, inventory systems, Excel, Smartsheet, and ERP platforms
Expertise in risk identification, assessment, and mitigation strategies
Experience managing multiple studies/programs and overseeing vendors, CMOs, and CROs
Budget tracking, cost control, and financial oversight of clinical protocols
Strong problem-solving and decision-making skills with a risk-based approach
Proficient in MS Office tools, including Excel, PowerPoint, Visio, and Project

Job Responsibility

Manage end-to-end clinical supply chain activities, including IRT, packaging, labeling, distribution, inventory management, returns, destruction, and study closeout
Ensure timely and complete achievement of protocol milestones, such as FPI, SIV readiness, and on-time site/patient deliveries
Collaborate with Clinical Operations, QA, Regulatory, and CMOs to ensure efficient and compliant execution
Identify, escalate, and mitigate risks related to delays, deviations, and supply disruptions
Oversee temperature excursions and supply deviations, ensuring proper documentation and resolution
Maintain compliance and inspection readiness across all execution activities
Monitor inventory levels and supply availability across programs
Contribute to process improvements, tools, and ways of working within the clinical supply chain
Train and mentor other trial leads to enhance team capabilities

Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Moderna is seeking a Senior Product Manager – Clinical Safety and Pharmacovigila...

Location

United States , Cambridge, Massachusetts; Bethesda, Maryland

Salary:

145900.00 - 234200.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Prior 7+ years' experience in the pharmaceutical or biotechnology industry
Strong domain expertise in Pharmacovigilance, including safety case processing, aggregate reporting, and post-marketing surveillance
Demonstrated product management experience delivering technology solutions in a life sciences or healthcare environment
Hands-on experience serving as System Owner for validated GxP systems
Solid working knowledge of GxP, GAMP5, and regulatory expectations for computerized systems supporting safety operations
Familiarity with Argus Safety, Veeva Vault and other PV ecosystem platforms and integrations
Experience working with agile software development teams in a digital product model
Ability to collaborate across time zones and cultures
strong cross-functional communication and influence skills
A mindset focused on curiosity, ownership, and continuous learning, aligned with Moderna Mindsets

Job Responsibility

Serve as System Owner for Clinical Safety and Pharmacovigilance systems, accountable for end-to-end system operations, governance, and lifecycle planning
Manage and continuously improve the release management process, including planning, testing, and deployment of new system features and enhancements
Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, and Regulatory teams
Contribute to the definition and delivery of the product strategy and roadmap in alignment with business needs
Support execution of the roadmap by coordinating initiatives across functions
Support the evaluation and implementation of innovative capabilities such as AI/ML to enhance safety operations
Collaborate with agile software squads to develop and deliver custom features and scalable solutions supporting safety operations
Contribute domain knowledge to adjacent systems and processes, including regulatory information management and quality compliance systems
Proactively challenge existing solutions and workflows, identifying opportunities for simplification, optimization, and innovation
Operate effectively in a global, cross-timezone team environment with colleagues and partners in the U.S., Poland, and India

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
annual discretionary bonus
other incentive compensation
equity award

Fulltime

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Global Clinical Delivery Manager

Job Description

Job Responsibility

Requirements

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