Associate Manager Clinical Support Job at Elevance Health (Virtual)

Clinical Research Associate II/Sr. Clinical Research Associate - Oncology

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part t...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
Must be fluent in English and in the native language(s) of the country they will work in
Ability to travel 60-80%
Valid driver’s license and passport required
Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

Job Responsibility

Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
Serve as the primary point of contact for assigned investigator sites
Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
Provide protocol training to, and address protocol related questions from the investigator site staff when required
Attend investigator meeting when required (virtual or F2F)
Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Associate Director, Clinical Data Management

The Associate Director, Clinical Data Management plays a key role within the Cli...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

At least 10 years of experience in clinical data management, including direct collaboration with CROs and data management vendors
Comprehensive knowledge of FDA and ICH/GCP regulations and their application to data management processes
Proficiency in CDISC standards (CDASH/SDTM), medical coding dictionaries, 21 CFR Part 11 compliance, and industry best practices in clinical data management
Exceptional interpersonal, communication, and organizational abilities, with a demonstrated capacity to manage multiple programs and workflows in a dynamic, team-oriented setting
Proven success in managing vendor relationships and functional service provider (FSP) partnerships
Strong track record of building effective relationships and managing expectations with external partners and vendors
Practical experience with electronic Trial Master File (eTMF) systems related to CDM documentation
Bachelor’s degree or higher in Life Science or related discipline

Job Responsibility

Provide project-level leadership for clinical data management (CDM) activities, monitor and report on overall study progress
Develop and maintain study timelines and ensure timely delivery of data-related milestones in collaboration with cross-functional teams and external vendors
Oversee the creation of study-specific CDM documentation, including eCRF specifications, completion guidelines, edit check specifications, and data management plans—proactively identifying and mitigating risks to data quality and ensuring appropriate filing in the Trial Master File (eTMF)
Manage CRO CDM counterparts to ensure compliance with scope of work, contractual agreements, timelines, and quality standards
Conduct end-to-end testing of electronic case report forms (eCRFs), including authoring and executing User Acceptance Test (UAT) plans and scripts prior to deployment
Develop and execute risk mitigation and action plans as needed to maintain data integrity and operational efficiency
Actively participate in internal study team discussions and engage with external stakeholders through vendor teleconferences
Serve as a primary liaison to internal partners (Clinical Operations, Biometrics, Safety/Pharmacovigilance, Regulatory Affairs) and external entities (CROs, third-party data vendors)
Monitor vendor performance and quality
escalate issues to management and implement corrective actions as appropriate

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Associate Vice President, Clinical Data Management

The Associate Vice President, Clinical Data Management is a member of the Global...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or master’s degree with 25+ years of data management experience
10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment
Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM)
Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen’s global clinical development efforts
Expertise in AI/ML-driven data management solutions, automation, and advanced analytics
Understanding of clinical data standards (CDISC, SDTM, ADaM)
Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions
Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management
Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams

Job Responsibility

Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals
Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases
Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows
Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums
Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance
Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization
Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues
Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions
Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics
Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data

Analyst, Clinical Data Management, Clinical Informatics-Ambulatory

As part of the Epic team, you will be expected to be proficient in all critical ...

Location

United States , Work From Home

Salary:

83430.00 - 222480.00 USD / Year

CVS Health

Expiration Date

March 02, 2026

Requirements

Minimum of five (5) years of related experience is required
Two or more Epic Certifications: EpicCare Ambulatory, Healthy Planet, Beacon, Willow, Prelude, Cadence, Resolute Professional Billing, HIM (Health Information Management), MyChart, Beaker, Welcome Kiosk, Rover, Haiku, EpicCare Link, Caboodle, SlicerDicer, Bridges, Reporting Workbench, Orders
Bachelor's degree is required or equivalent experience
Strong experience configuring, designing, and supporting an Epic solution
Previous application configuration experience
Knowledge of Ambulatory workflows and quality and safety initiatives
Experience in test planning & execution, test case development, and meeting project quality requirements
Experience working on large projects, strong knowledge of clinical applications and understanding of the healthcare IT industry
Understanding of configurable applications and monitoring practices
Analytical, problem resolution and interpersonal skills

Job Responsibility

Design and develop and facilitate deployment of the quality and safety initiatives
Oversee build and maintenance of Epic environments, related in particular to Medical Affairs safety efforts
Facilitate communication and problem solving sessions to identify, scope and plan for safety mitigation plans
Maintain comprehensive documentation of materials and methodologies, user guides, and support resources
Create and fulfill EHR use cases, identify business and functional requirements and working closely with IT resources to translate requirements and workflows to technical specifications
Lead documentation efforts for discovery and implementation
Ensure requirements and future state workflows are clearly defined
Support development of Quality and Safety Governance and guidance group supporting both Oak Street Health and all CVS business units
Work with across the CVS enterprise to identify tasks and associated business units impacted by quality & safety efforts
Support execution of vendor upgrades, system changes and environment maintenance procedures

What we offer

Affordable medical plan options
401(k) plan with matching company contributions
Employee stock purchase plan
No-cost wellness screenings
Tobacco cessation and weight management programs
Confidential counseling and financial coaching
Paid time off
Flexible work schedules
Family leave
Dependent care resources

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

Clinical Project Associate

An ideal candidate for our Clinical Project Associate position is an individual ...

Location

Salary:

23.00 - 28.00 USD / Hour

canfield scientific

Expiration Date

Until further notice

Requirements

Associate degree or at least 1 year work experience
Proficiency in Microsoft Office
Strong time management, problem-solving, and organizational skills
Ability to adjust to shifting priorities and meet timelines
Detail oriented, flexible, and works well within a team environment

Job Responsibility

Provide project management and operational support to designated clinical project team ensuring that quality, timelines, and project specifications are met
Manage study documentation ensuring accuracy within the documentation while aiding in the preparation of supply shipments to study sites
Setup, maintain, and update databases and assist with data query resolution
Perform quality control checks to ensure the integrity of data and may support initiation phase of project
Communicate with study sites by fielding, answering, and directing questions to obtain information and direct to corresponding personnel

What we offer

Paid days off
Medical, dental, and vision insurance
May be eligible for a discretionary bonus
401(k) plan with employer match (currently set at 50%)

Fulltime

Clinical Trial Operations Associate

Beacon Biosignals is on a mission to revolutionize precision medicine for the br...

Location

United States , Boston

Salary:

Not provided

Beacon Biosignals

Expiration Date

Until further notice

Requirements

Experience in clinical project management or clinical operations roles
Strong organizational and project management skills, with the ability to manage multiple responsibilities effectively
Excellent written and verbal communication skills in English
A proactive mindset with the ability to identify priorities and anticipate challenges
Meticulous attention to detail, ensuring accuracy in data collection and reporting
Familiarity with GCP, ICH guidelines, and clinical research regulatory requirements
A desire to learn more about analytics, statistics, machine learning, and clinical trials

Job Responsibility

Collaborate with project teams to support study startup activities
Act as the primary point of contact for clinical sites, ensuring smooth operations and clear communication
Provide training to research sites on the use of Beacon’s devices and study protocols, ensuring proper device usage and data collection
Monitor project progress, ensuring adherence to timelines, protocols, and quality standards
Maintain compliance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and regulatory standards
Address operational issues promptly, escalating through tools like Zendesk and Asana for resolution
Provide actionable feedback from research sites to inform improvements in devices and workflows

What we offer

equity
PTO

Senior Clinical Research Associate

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

Location

Taiwan , Taipei

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant field such as life sciences, nursing, or medicine
Extensive experience as a Clinical Research Associate, with a strong understanding of clinical trial processes and regulatory requirements
Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills
Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools
Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment
Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver’s license

Job Responsibility

Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards
Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution
Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting
Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct
Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations

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

Associate Manager Clinical Support

Elevance Health

Location:
United States of America , Virtual

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 05, 2026

Expiration:
January 06, 2026

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Nice to have:

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Expiration:January 06, 2026

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