Clinical Data Manager Job at Amaris Consulting (Barcelona, Lyon, Paris, Madrid)

Senior Technical Product Manager (Clinical Data Platform)

As a Senior Technical Product Manager, Clinical Data Platform, you will be a key...

Location

United States

Salary:

Not provided

Aledade, Inc.

Expiration Date

Until further notice

Requirements

8+ years of product management experience in healthcare technology, technology-enabled services industry, or a SaaS product
Experience using data and primary research to inform solution design and build internal business understanding
Experience with and understanding of the software development lifecycle and software development methodologies, including experience managing within Agile and Scrum teams
Product development experience in the context of the development of a healthcare technology product

Job Responsibility

Partner with business owners to cultivate a shared vision for the problem space, constraints, priorities and ideal end state, and be able to articulate and advocate for this perspective
Ongoing optimization of live user workflows and capabilities including monitoring of key metrics & internal user feedback
Work with internal teams and end users to develop a deep understanding of requirements, perform thoughtful technical solution designs, use data to test hypotheses, and support teams throughout execution
Write detailed user stories for new features, capturing detailed descriptions of business rationale, requirements, and success criteria that are defined by measurable outcomes
Develop short- and long-term roadmaps that deliver maximum value with minimum risk and assume ongoing iteration

What we offer

Flexible work schedules and the ability to work remotely are available for many roles
Health, dental and vision insurance paid up to 80% for employees, dependents and domestic partners
Robust time-off plan (21 days of PTO in your first year)
Two paid volunteer days and 11 paid holidays
12 weeks paid parental leave for all new parents
Six weeks paid sabbatical after six years of service
Educational Assistant Program and Clinical Employee Reimbursement Program
401(k) with up to 4% match
Stock options

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

Clinical Data Analyst

AB Science is hiring a Clinical Data Analyst based in Paris. Responsibilities co...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Male or female with University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline
At least 5 years of experience in Clinical trials, preferably in Clinical Data Management
Knowledge of clinical development process
Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training
Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
MedDRA coding certification is a plus
WHODD coding certification is a plus

Job Responsibility

Ensure the clinical consistency of data used for statistical analyses and clinical study reports
Clinical data to be check includes laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments
Follow-up the resolution of detected issues/inconsistencies via queries process
Participate to the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan
Ensure Clinical Data Management input to other relevant strategic study documents and vendor contracts
Detect important medical events
Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database
Detect the forbidden concomitant treatments as per study protocol
Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team
Archive documents in the clinical data management TMF

What we offer

Permanent position
Salary & package to define according skills and experience

Fulltime

Program Manager Clinical Risk Management and Patient Safety - Quality Management

This role also works in conjunction with the System Director of Clinical Risk Ma...

Location

United States , Tyler

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in healthcare-related field required
5 years of healthcare risk management experience required
Proficiency with Microsoft Word, Excel, and PowerPoint required
Certified Professional in Patient Safety (CPPS) or Certified Professional in Healthcare Risk Management (CPHRM) required within 1 year of hire

Job Responsibility

Assists in identifying and evaluating activities or events occurring within the system and facilities, which may affect patient safety, resulting in either patient injury and/ or a potential opportunity to improve care delivery and patient safety
Facilitates implementation and management of a system clinical adverse event investigation process and provides consultation to facility and system staff
Provides leadership for conducting patient safety/ clinical risk assessments and adverse event investigations including root cause analyses and implementation of effective corrective action plans
Demonstrates a high degree of professionalism and communication skills when working with staff involved in adverse events, promoting a culture of no blame and collaboration
Facilitates, tracks, and maintains appropriate records and metrics regarding adverse events and potential for patient and staff safety issues
Uses data and trend analysis experience to facilitate system efforts to analyze data including metrics, surveys, occurrence reports, adverse event investigations, FMEAs, and other information to identify and prioritize clinical risk management/ loss prevention, and patient and staff safety concerns
Supports and contributes to system efforts to carry out FMEAs regarding clinical risk management/ loss prevention, as well as patient and staff safety concerns
Carry out other duties as assigned by leadership
Strive to increase and share current knowledge in the areas of clinical risk management and patient and staff safety
Possesses excellent organizational and analytical skills

Fulltime

Data Manager

Data Manager position at AB Science in Paris, specializing in clinical data mana...

Location

France , Paris

Salary:

Not provided

AB SCIENCE

Expiration Date

Until further notice

Requirements

Male or female with 4/5 years higher education degree and with a specialization in Data Management or Statistics
At least 3 years’ experience in clinical data management
Programming experience with SAS software required
Good knowledge of EDCs
Fluent in English

Job Responsibility

Ensure coordination of data management activities with the internal teams
Carry out the extraction of the data to be made available to the statisticians
Write the Data-Management plan and schedule/validate the consistency tests in Capture system and SAS
Design the paper CRF and eCRF in accordance with the study protocol
Review the queries generated before sending to investigators

What we offer

Permanent position
Available immediately

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 Associate Data Management

The Senior Associate, Data Management, will help drive key business operation in...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
In depth understanding of the Veeva Vault system
Good written and verbal communication skills
Detail oriented
Independent time management and prioritization skills
Work efficiently with little support and minimal to no supervision
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
Critical thinking skills
Appropriate software skills as required
Strong analytical and problem solving, communication and presentation skills

Job Responsibility

Responsible for maintaining data within the Regulatory Information Management (RIM) system
Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system
Serve as a Data Management SME within cross-functional collaborative initiatives
Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives
Provide support on creating, running and analysing reports for data streamline projects
Develop and deliver training materials and presentations to a global audience
Manage the protocol Amendment New Investigator (PANI) submission updates
Manage 1572 forms for FDA submission
Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods
Adhere to Amgen processes, policies, guidelines, SOPs and training documentations

What we offer

Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Clinical Program Success Manager

Your North Star: Deliver an exceptional experience to clinicians providing care ...

Location

United States

Salary:

95000.00 - 110000.00 USD / Year

Pomelo Care

Expiration Date

Until further notice

Requirements

Prior experience working within a healthcare environment, either as a clinician or as a team leader of clinicians
Strong interpersonal skills and demonstrated ability to engage with a diverse population. Demonstrated ability to build trusting relationships in a virtual environment
Excellent written and verbal communication skills. Demonstrated ability to drive change management with large frontline teams at scale. Comfort leading difficult conversations 1:1
Strong sense of ownership, with demonstrated experience partnering cross-functionally to find answers and to find solutions quickly and independently. Able to own processes end-to-end and ensure that all steps are completed accurately
Strong project management skills and attention to detail, ensuring that every step is understood accurately, completed in full, and communicated effectively
Comfort using data to inform prioritization and decision-making
Ability to adapt to changing priorities and work effectively in a fast-paced environment. Willingness to learn new processes and systems, and to teach them to others

Job Responsibility

Act as the primary internal point of contact for clinicians delivering care across our pilot programs
answer questions, provide feedback, and monitor utilization
Design the onboarding and training program for new clinicians, in partnership with the Training team, and ensure that all providers complete onboarding and training in a timely manner
Own communication and change management to clinicians regarding important updates, using scalable and effective methods
Maintain an up-to-date clinician handbook with accurate details on our offering, such as services included, documentation expectations, and required scripting
Ensure that clinicians meet the expectations of our client sponsors, including documentation requirements, quality standards, and preferred partners
Use data to identify areas for improvement at the individual and team level
escalate programmatic areas of opportunity and provide coaching to specific clinicians, as needed
Build relationships with relevant community clinician groups to support recruitment, build trust within the community, and stay informed of market trends

What we offer

Competitive healthcare benefits
Generous equity compensation
Unlimited vacation
Membership in the First Round Network (a curated and confidential community with events, guides, thousands of Q&A questions, and opportunities for 1-1 mentorship)

Clinical Data Manager

Amaris Consulting

Location:

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
April 11, 2026

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