Manager, Clinical Data Management Job at Alfasigma (Milano)

Data Manager, Clinical Data Sciences

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit wit...

Location

Argentina , Buenos Aires

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Strong knowledge / understanding of clinical development and pharmaceuticals as a regulated industry
Strong knowledge / understanding of healthcare regulatory authorities (e.g. FDA, Health Canada)
Ability to learn clinical data management processes and principles in area of responsibility
Minimum 1-3 years Data Management experience required
Demonstrates required verbal and written communication skills including ability to communicate remotely
Capable to learn technical data systems
Capable to learn how to use data visualization tools (e.g. Spotfire, J-Review)
Awareness of MedDRA/WHO-Drug preferred
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Bachelor’s degree minimum requirement

Job Responsibility

Participate in CDS activities including data review and query management
Assist with quality database design including documentation, testing, validation, and implementation of clinical data collection tools, CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems
Ensure work carried out in accordance with applicable SOPs and working practices
Ensure the required study-specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection and submission readiness activities
Ensure operational excellence in collaboration with Data Manager and CDS for application of standards, data acquisition, proactive data review and query management, data cleaning, e-data processing, data access and visualization, DM metrics reporting, database release, and submission related activities

Fulltime

Manager, Central Monitor, Data Surveillance, Clinical Data Sciences

As part of the Clinical Data Sciences (CDS) group, an integral delivery unit wit...

Location

India , Chennai

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Bachelor’s degree or above in a scientific or business related discipline required
Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.
Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations
Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
Works independently, receives instruction primarily on unusual situations
Ability to organize tasks, time and priorities
ability to multi-task
Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally

Job Responsibility

Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables
Provide technical expertise to set up and test study level Risk-based Monitoring system
Review study level system outputs to process for the signal and action management
Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study
Able to resolve conflicts, influence and communicate cross-functionally with key stakeholders and customers
Set up and test RBM system at study level to ensure system quality
Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level
Ensure RBM system alignment with the protocol and adherence to ICH GCP, SOPs, corporate standards and regulatory requirements
Work with Study Team to define the issue resolution for the review of findings as signals and actions
Develop, implement and maintain Quality Control related documentation for RBM related activities to ensure data completeness and accuracy

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

Lead Data Scientist - Clinical Informatics (Clinical Data Standards)

We’re building a world of health around every individual — shaping a more connec...

Location

United States , New York

Salary:

130295.00 - 260590.00 USD / Year

CVS Health

Expiration Date

June 29, 2026

Requirements

7+ years of relevant experience in clinical informatics, healthcare analytics, or clinical data management
Deep expertise in clinical data types and structures, including CCD data, lab results, clinical notes, and administrative healthcare data
Strong knowledge of clinical coding systems and terminologies, such as ICD-10, CPT, HCPCS, SNOMED-CT, LOINC, NDC, and RxNorm
Experience designing and documenting data models, taxonomies, or classification frameworks for clinical or healthcare data
Proven ability to enable and support downstream data consumers (analysts, data scientists, business users) through documentation, training, and consultative support
Experience leading cross-functional projects from concept to delivery by coordinating across clinical, technical, and business stakeholders
Proficiency with SQL and experience working with large-scale healthcare datasets
Experience using cloud-based data platforms, preferably Google Cloud Platform (GCP) tools including BigQuery, for querying, transforming, and managing data
Strong understanding of data quality principles, including validation, profiling, and monitoring of healthcare data
Excellent written and verbal communication skills, including the ability to explain complex clinical data concepts to both technical and non-technical audiences

Job Responsibility

Serve as a subject matter expert in clinical data, including CCD data, with deep understanding of how to structure and apply this data to solve healthcare problems
Design and maintain clinical data models, taxonomies, and classification frameworks that enable consistent interpretation and use of clinical data across the organization
Develop and govern the clinical data feature store, establishing standards, documentation, and best practices that accelerate adoption of clinical data for downstream analytics, reporting, and AI/ML use cases
Enable self-service analytics by building well-documented, validated, and reusable data assets (tables, views, features) that empower analysts and data scientists to work independently with clinical data
Create and maintain comprehensive data documentation, including data dictionaries, lineage, business logic, known limitations, and appropriate use guidelines for clinical datasets
Build queries, dashboards, and data visualizations to effectively communicate data quality metrics, data availability, and clinical insights to technical and non-technical stakeholders
Partner with clinical, operational, and business stakeholders to understand their data needs, translate requirements into data solutions, and ensure clinical data assets meet their analytical objectives
Lead and mentor data scientists, data analysts, and data engineers, providing guidance on clinical data interpretation, appropriate use, and best practices for working with healthcare data
Establish data quality frameworks for clinical data, including validation rules, anomaly detection, and monitoring processes to ensure data integrity and reliability
Translate clinical concepts into analytical frameworks, ensuring that business partners understand the capabilities and limitations of available clinical data

What we offer

Medical, dental, and vision coverage
Paid time off
Retirement savings options
Wellness programs
CVS Health bonus, commission or short-term incentive program
Award target in the company’s equity award program

Fulltime

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Clinical Trial Manager/ Sr Clinical Trial Manager (PM/ Sr PM)

Clinical Operations Lead - Early Development Oncology. ICON plc is a world-leadi...

Location

United States , Raleigh, Blue Bell

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

BS/BA degree or a relevant degree with strong emphasis on science, or equivalent experience
Minimum of five years of relevant experience in the biopharmaceutical industry or other relevant clinical research experience, with a focus on skills and competencies
Must have working knowledge of ICH Good Clinical Practices and other relevant regulatory/health
Prior experience in assisting the conduct and management of multinational clinical trials is preferred
Ability to effectively manage multiple priorities across several protocols and therapeutic areas simultaneously
Experience in oncology studies required (phase I preferred)

Job Responsibility

Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department
Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway
Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial
Monitor study-specific timelines and key deliverables
focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc)
Participate as a member of the multi-disciplinary trial(s) team
Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed
Participate in data review and discrepancy resolution as needed
Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments
Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate

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

Project Manager/RTE & Scrum Master - AI-Driven Clinical Data Management

We are looking for a pragmatic, hands-on servant leader who thrives in ambiguity...

Location

Switzerland , Basel

Salary:

Not provided

Randstad

Expiration Date

July 31, 2026

Requirements

7+ years of project management experience in software delivery, including 3+ years managing programmes with multiple parallel teams
Demonstrated Scrum Master experience - you have facilitated agile teams, not just observed them. You know how to run an effective retro and how to coach without directing
Pharmaceutical or Life Sciences industry experience with understanding of GxP requirements and what inspection readiness means in practice
Hands-on Jira experience - you have configured and managed Jira projects, not just consumed reports. Xray test management experience preferred
Experience with scaled agile delivery (SAFe or similar) and the pragmatism to know when to adapt the framework to the situation
Strong risk and dependency management skills with a bias toward action
Experience managing distributed hybrid teams across multiple time zones
Fluent English communication - written and verbal

Job Responsibility

Programme Delivery Management: Own the delivery plan across multiple parallel teams from current state through MVP and subsequent releases
Drive PI-level planning, manage cross-team dependencies, and resolve blockers before they hit the critical path
Maintain the RAID log with clear owners, deadlines, and recommendations
Enforce scope discipline through a structured requirements intake and triage process
Release management: develop and maintain a release calendar and schedule, coordinating with development, QA, and operations teams on timelines. Lead post-implementation reviews to identify release cycle process improvements
Scrum Master for Three Delivery Teams: Facilitate sprint planning, daily standups, reviews, and retrospectives for the teams
Shield teams from external disruptions and remove impediments quickly
Coach team members on agile practices and continuous improvement
Track sprint health (velocity, burndown, blocked items) and surface concerns early
Support Product Owners with backlog refinement, story breakdown, and Definition of Done compliance

Fulltime

Associate Director/Director, Clinical Data Management

The Associate Director / Director of Clinical Data Management is responsible for...

Location

United States , San Mateo

Salary:

162000.00 - 240000.00 USD / Year

Dompé

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Computer Science, or related discipline
12+ years of progressive experience in clinical data management, with at least 5 years in a leadership or oversight capacity
Extensive experience with Medidata products (Rave EDC, RTSM, Coder, integrations)
Proven ability to oversee multiple global studies and CROs concurrently
Deep understanding of clinical data management processes, data standards (CDASH, CDISC), and technology landscape
Experience in authoring and implementing SOPs, WIs, and operational best practices
Demonstrated success in supporting regulatory submissions (NDA, BLA, MAA) and managing inspection readiness
Strong leadership, problem-solving, and decision-making skills with the ability to operate independently
Excellent communication, organizational, and stakeholder management skills
Experience with budget forecasting, cost tracking, and resource planning for multi-study portfolios

Job Responsibility

Lead data management strategy across multiple studies and programs, ensuring alignment with corporate and regulatory objectives
Oversee CROs and external partners to ensure consistent quality, compliance, and timely delivery of study data
Act as the primary point of contact for data management oversight, providing direction, decision-making, and escalation management
Ensure study-level data standards, quality metrics, and processes are defined and consistently applied
Manage all data management activities from study start-up through database lock and close-out
Oversee development and execution of Data Management Plans (DMPs), edit check specifications, external data transfer agreements, and data validation activities
Ensure data collection systems, workflows, and integrations align with protocol requirements and regulatory expectations
Provide oversight for database design, User Acceptance Testing (UAT), and database release readiness
Lead governance and performance management of CROs supporting data management functions
Review and approve study deliverables (CRFs, DMPs, edit checks, transfer specs, listings, and reconciliation plans)

What we offer

Comprehensive medical benefits
Generous vacation / holiday time off
Competitive 401(K) matching
Incentive bonus

Fulltime

Clinical Data Manager II/III

Location

Poland

Salary:

Not provided

GRUPA NEUCA

Expiration Date

Until further notice

Requirements

university degree (bioengineering, life science or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution
fluency in English
minimum 2 years of experience in effective clinical data management practices
excellent knowledge of MS Excel
ability to analyze information and draw conclusions, initiate appropriate solutions
independence in planning activities, resources and time to achieve the set goals and objectives
communication skills, teamwork and ability to contact with the client in order to learn about and solve problems

Job Responsibility

taking the role of Lead Data Manager for allocated projects
accountability for all DM deliverables per the established timeline
providing instruction to DM study team and reviewing their study team's output while adjusting
resource allocations within the project accordingly
overseeing all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCP
working with the Project Manager to build timelines to meet contracted milestones by communicating with leads in different disciplines and the project team
maintaining awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies
ensuring service and quality agreed upon specifications per the DMP and scope of work
performing quality control in all aspects of the study
reconciling the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilising local laboratory systems and batch data load facilities where appropriate

What we offer

work in a developing CRO in Poland with foreign branches
recommending appropriate solutions in projects
impact on changes in processes in the Data Management area
stable employment in the company awarded Top Employer 2026
work in an international team
remote work
private medical care
free legal advice
social benefits
employee referral program

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Manager, Clinical Data Management

Job Description

Job Responsibility

Requirements

What we offer

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