Senior Associate Clinical Contracts & Budgets Job at Amgen (Bucharest)

New

Clinical Pricing & Payments Senior Associate - Pricing

Investigator Pricing Analyst Home based Spain. ICON plc is a world-leading healt...

Location

Spain , Barcelona

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

3 years' work experience in financial support or contract administration role
Creation of site level clinical trial budgets
BA/BS/BSc

Job Responsibility

Support Global Development Operations, Global Study and Clinical Management Groups and Therapeutic Area Teams by creation of pricing proposals for clinical study budgets, consulting and related agreements
Support Finance in the development of study level budget estimates using pricing tools
Development of fair market value negotiation guidelines for each pricing request
Maintain database of information related to pricing
Ownership of pricing tools and templates/forms
Participating in team/department special projects as required
Receive pricing requests from Clinical Development Study Clients for original or amended budgets
Review study protocol or consulting scope of work and discuss with Clinical Study Team
Use industry benchmarking pricing tool(s) and internal historical data to create base clinical study budget or recommendation for consultant or services compensation
Create budget spreadsheet and corresponding documentation to be incorporated into Agreement

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

Senior Clinical Study Associate

Be the backbone of clinical research-join a team shaping tomorrow's therapies. P...

Location

United States , Cambridge

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong understanding of clinical trial processes and regulatory requirements
Experience with TMF management and document tracking
Proficiency in managing laboratory vendors and coordinating sample logistics
Ability to review and analyze site performance metrics and monitoring reports
Excellent organizational and communication skills
Familiarity with site contracts, budgets, and feasibility assessments
Ability to work collaboratively with cross-functional teams and external vendors

Job Responsibility

Oversee day-to-day clinical trial execution, including site start-up, patient enrollment, and monitoring
Support the Clinical Study Manager and team members in managing trial activities
Prepare study documents such as consent forms, site instructions, and study-specific materials (e.g., Manual of Operations, Pharmacy Binder)
Track essential documents, ensuring accuracy and proper filing in the Trial Master File (TMF)
Monitor patient status at investigative sites and ensure accurate tracking
Manage sample collection, laboratory testing schedules, and central laboratory reporting
Assist with laboratory vendor management and liaise with CROs and clinical trial sites for sample handling and result reporting
Review monitoring trip reports, track data query reports, and assess site visit metrics and performance
Participate in site initiation, routine monitoring, and close-out visits, including co-monitoring with CROs
Ensure data quality from clinical sites and assist in resolving subject eligibility and protocol deviation issues

Senior Analyst - Financial - Clinical Research

The Senior Financial Analyst will serve as a subject matter expert in coverage a...

Location

United States , Hollywood

Salary:

Not provided

Memorial Healthcare System

Expiration Date

Until further notice

Requirements

Bachelors (Required)
Three (3) years experience with coverage analysis, clinical trial budget development and negotiation, clinical research study coordination or management, health system operations, or other related research or healthcare experience
A Bachelor s degree in finance, science, business, healthcare administration or related field experience
Critical thinking skills
Effective communication
Decisive judgment
Ability to build and foster positive relationships
Ability to work with minimal supervision

Job Responsibility

Performs comprehensive and independent analysis of clinical trial protocols and other study documents, including the research study budget, contract, informed consent, pharmacy and lab manuals, and other supporting documentation
Perform detailed coverage analysis of research procedures in alignment with CMS rules and develop audit-ready study billing grids
Assist Research Specialists in determining study status under Medicare coverage rules and in identifying services as non-covered research-only, routine care, investigational items, and services along with their associated costs
Lead the development, implementation, analysis and validation of clinical trial financial systems design and operational workflows to optimize performance and productivity
Ensure electronic and paper study files are created, updated, stored, and maintained according to established office practices, and MHS record retention policies, from initial contact to study closeout and beyond
Review and scrub patient bills to ensure claims are being processed accordingly and routed to the correct payor
Analyze industry sponsor budget proposal, clinical trial protocol and manuals to develop and negotiate comprehensive study budgets and payment terms

Fulltime

Senior Clinical Research Associate

Senior Clinical Research Associate - Oncology - East Coast. ICON plc is a world-...

Location

United States , Atlanta; Texas; Maryland; Missouri; Tennessee; North Carolina; Illinois; Ohio; Florida; Philadelphia, PA

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution
a licensed health care professional (i.e. registered nurse) or equivalent work experience required
5+ years clinical monitoring experience required (Sr CRA)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English
Oncology monitoring experience required
Experience doing feasibility/site selection/site start up required
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

Job Responsibility

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines
Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites
Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations
Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Provides regular site status information to team members, trial management, and updates trial management tools
Completes monitoring activity documents as required by sponsor's SOPs
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
Escalates site and trial related issues per Sponsor's SOPs until identified issues are resolved or closed
Performs essential document site file reconciliation
Performs source document verification and query resolution

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

Director, Clinical Applications

The Director, Clinical Applications will plan, direct, and oversee all aspects o...

Location

United States , Denver

Salary:

136400.00 - 177400.00 USD / Year

InnovAge

Expiration Date

Until further notice

Requirements

Bachelor's degree in computer science, health informatics, or related technical field
10+ years of progressive leadership experience in healthcare technology organizations, with direct accountability for clinical application portfolios and functional team management
Deep knowledge and experience in a multi-disciplinary approach to healthcare technology, with specific experience managing clinical application ecosystems in PACE, senior care, or complex care coordination environments
Proven ability to lead and build strong, scalable, and diverse teams
demonstrated success leading geographically dispersed teams across clinical, technical, and operational disciplines
Healthcare experience is required, with hands-on knowledge of Epic EHR (including configuration, optimization, and FHIR API/interoperability capabilities), and familiarity with complementary clinical systems
Experience with Agile methodology and iterative delivery in regulated healthcare environments
Demonstrated experience hiring, managing, developing, and retaining highly technical staff and leadership in competitive healthcare IT markets
Demonstrated experience leading complex technology development and regulatory compliance projects on time and within budget, including EHR implementations, interoperability initiatives, and security hardening programs
Demonstrated experience leading operations and support teams, ensuring service levels are defined, met, and auditable for regulatory purposes (HIPAA, SOX)

Job Responsibility

Develops, procures, and deploys clinical technology solutions from concept through build/configure, integration, testing, and production deployment, including AI-enabled clinical tools and interoperability capabilities aligned with recognized standards
Operate, maintain, and support clinical technology solutions to meet service-level commitments, including Epic EHR, telehealth, in home services, and dental platforms
Balance demand management for multiple complex simultaneous projects, operational enhancements, regulatory compliance initiatives, break-fix, and maintenance requests
Partner with clinical, operational, and compliance teams to optimize workflows and design technology solutions that deliver value, exceptional user experience, and excellent outcomes for PACE participants and their caregivers
Research, recommend, and develop workflow solutions—including agentic AI, clinical decision support, and predictive analytics—to streamline processes, improve care quality, reduce costs, and enhance user experience
Collaborate with business stakeholders to create multi-year capability roadmaps that incorporate regulatory milestones (HIPAA Security Rule enforcement, CMS interoperability deadlines), grooming backlogs quarterly to create release packages/dates
Ensure all projects, initiatives, and processes conform to organizational policies, regulatory requirements (HIPAA, SOX), and are on schedule and within budget
Lead, mentor and develop the performance of the applications team
Collaborate across all IT functions to deliver sustainable, resilient platforms and applications, including the Cloud/Infrastructure, Integration, Architecture, and Data teams
Responsible for release and change management, coordination, and adherence to quality standards for multiple clinical technology solutions

What we offer

medical/dental/vision insurance
short and long-term disability
life insurance and AD&D
supplemental life insurance
flexible spending accounts
401(k) savings
paid time off
company-paid holidays

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior Clinical Associate

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

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

At least Bachelor degree
At least 2 years of experience as CTA (working for Pharmaceutical or CRO company)
Planning and organizational skills
Advanced communication skills

Job Responsibility

Adhere to applicable SOPs WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Comply with relevant training requirements
Assist in trial specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness
Assist in IP and ancillary supply management, including ordering, distribution, and tracking
Ensure the current trial status and tracking of trial related information is available at all times in the appropriate Clinical Trial Management System(s) (CTMS) and/or tracking tools
Ensure trial specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers and Site Managers
Ensure trial delivery according to the agreed upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables
Run data & metric reports in support of trial deliverables
Responsible for review/management of Trial Master File (TMF) for completeness and timely provision
Maintain key trial specific information, including trial contact list

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 maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Oncology Strategy Senior Manager

In this vital role you will support Amgen's Partners of Choice academic collabor...

Location

United States , Los Angeles

Salary:

148282.50 - 200617.50 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Oncology experience as a Strategy Senior Manager
Master's degree and 4 years of Oncology experience as a Strategy Senior Manager
Bachelor's degree and 6 years of Oncology experience as a Strategy Senior Manager
Associate's degree and 10 years of Oncology experience as a Strategy Senior Manager
High school diploma / GED and 12 years of Oncology experience as a Strategy Senior Manager

Job Responsibility

Support the Oncology Strategy Director in APoC strategy development, goal setting, execution of organizational plans, creation of organizational communications, project management and implementation of functional projects
Project Management support and oversight of new and ongoing APoC collaboration projects interfacing effectively with cross-functional groups including Clinical Development, Precision Medicine, Research, Clinical Operations, and Legal
Work with APoC Leadership to support operational areas such as budget, contracting, resource management, status reporting, network meeting support and process improvements projects
Drive the planning, preparation and execution of network-wide summits to achieve strategic objectives of the organization, including agenda preparation, presentation development, logistics planning and facilitating external speaker engagement
Development of internal and external communications including newsletters, meeting logistics and communications, and meeting presentations
Turn unstructured business issues/requests into appropriate action plans and projects that result in high quality, significant and impactful deliverables
Liaise with external contacts at APoC sites on behalf of Amgen

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Select Country

Senior Associate Clinical Contracts & Budgets

Job Description

Job Responsibility

Requirements

Looking for more opportunities?