Senior Clinical Data Manager I

hace 7 meses

Madrid, España Allucent A tiempo completo

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.

The Senior Clinical Data Manager I (CDM I) leads and coordinates Data Management (DM) deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.

This position also provides leadership and expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.

The Senior CDM I is a member of the Data Management staff.

**Key Responsibilities**

**_ Data Management_**
- Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites)
- Plan and project the resources required including management of tasks, timelines, risk and quality
- Keep track on budget, forecasts and manage changes of scope requests
- Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)
- Provide support on clinical study database set-up, including eCRF design and database validation requirements
- Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
- Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
- Create training materials for EDC users and provide project-specific training as required
- Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
- Create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
- Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.
- Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
- Perform medical coding tasks as needed
- Participate in conference calls and/or meetings with vendors and sponsors
- Manage the database implementation, lock and close-out processes and procedures
- Maintain documentation on an ongoing basis and ensure that all filing is up to date
- Plan and create necessary documentation to support internal and external audits; participates in such audits
- Provide leadership, expertise and support to other department members.
- Recognize and solve potential problems and evaluate effectiveness

**_Learning & Development_**
- Actively support staff learning & development
- Develop and deliver applicable DM departmental training
- Participate in the interview process for new recruits
- Train and mentor data management staff
- Proactively track data management development trends and updates, in consultation with department Global Head and/or Directors, for further alignment and improvement of current processes

**_Quality Management_**
- Contribute as Subject Matter Expert (SME) in the field of CDM activities to the evaluation/improvement and standardization of processes and procedures within the Quality Management System

**Requirements**:
**Qualifications**
- Life science, healthcare and/or related field degree
- Minimum 5-10 years of relevant work experience
- Minimum 5-10 years of experience in drug development and/or clinical research
- Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements
- Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)
- Experience in CDISC conventions, i.e., CDASH, SDTM model and hands on experience implementing these models
- Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies
- Ability to translate guidelines, rules and regulations in clear and usable recommendations

**Skills**
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence
- Strong project managem

  • Senior Clinical Data Specialist

    hace 3 semanas

    Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    Lead the Way in Clinical Data StandardsWe are a leading healthcare intelligence and clinical research organization, shaping the future of clinical development.This is an opportunity to work with our team as a Senior Clinical Data Specialist. As a key member, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical...

  • Clinical Trial Manager I Spain. Sponsor Dedicated

    hace 4 días

    Madrid, España Syneos Health Clinical A tiempo completo

    **Clinical Trial Manager I Spain. Sponsor dedicated.** **-** **(**22005967**)** **Description** **Clinical Trial Manager** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the...

  • Senior Clinical Data Manager

    hace 7 meses

    Madrid, España Precision for Medicine A tiempo completo

    **Position Summary**: The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines will be followed. This position...

  • Clinical Trial Manager I-ii Madrid. Sponsor

    hace 4 días

    Madrid, España Syneos Health Clinical A tiempo completo

    **Clinical Trial Manager I-II Madrid. Sponsor dedicated.** **-** **(**22004074**)** **Description** **Clinical Trial Manager II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around...

  • Principal Clinical Data Standards Consultant

    hace 2 meses

    Madrid, España Icon Clinical Plc A tiempo completo

    .Principal Clinical Data Standards Consultant - EMEAICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Principal Clinical Data...

  • Clinical Data Standards Specialist

    hace 1 semana

    Madrid, Madrid, España Icon Clinical A tiempo completo

    About ICON ClinicalICON Clinical is a world-leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development. Our diverse and dynamic team fosters an inclusive environment driving innovation and excellence.We are currently seeking a Principal Clinical Data Standards Consultant to join our team in...

  • Sr. Clinical Data Manager

    hace 5 días

    Madrid, España Cmed A tiempo completo

    Why Cmed? Cmed occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials for immuno-oncology and cell & gene therapies, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join Cmed, as we continue to leverage our considerable...

  • Director, Clinical Data Management

    hace 7 meses

    Madrid, España Caidya A tiempo completo

    We're seeking a Director of Clinical Data Management to join our team working remotely from any UK location — this pivotal role focuses on delivering the highest quality data management support. You will lead teams encompassing technical consulting, seamless client interface, and operational excellence. You'll be the face of our data management team,...

  • Principal Clinical Data Manager

    hace 4 días

    Madrid, España Labcorp A tiempo completo

    **Job Overview**:** Principal Clinical Data Manager - FSPx** **Home-Based** Are you an experienced Clinical Data Manager who is now looking to take on more responsibilities in a Principal Clinical Data Manager opportunity? This is a great opportunity for someone who wants to advance their career, in a Sponsor dedicated role, whilst working alongside the...

  • Clinical Data Standards Expert

    hace 3 semanas

    Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    We are seeking a skilled Clinical Data Standards Expert to join our team at Icon Clinical Plc. With a strong focus on innovation and excellence, we foster an inclusive environment that drives growth and development.As a Clinical Data Standards Consultant, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical...

  • Senior Clinical Data Analyst

    hace 2 semanas

    Madrid, Madrid, España Pivotal A tiempo completo

    Job SummaryWe are seeking a highly skilled Senior Clinical Data Analyst to join our team at Pivotal, a leading full-service contract research organization in Europe. As a Senior Clinical Data Analyst, you will play a crucial role in supporting clinical trial operations by designing and implementing data analytics solutions using AI methods.About UsPivotal is...

  • Clinical Trial Manager Ii

    hace 5 días

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II, Real World & Late phase studies** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and...

  • Principal Clinical Data Standards Consultant

    hace 2 meses

    Madrid, España Icon Clinical Plc A tiempo completo

    Principal Clinical Data Standards Consultant - EMEAICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Principal Clinical Data...

  • Principal Clinical Data Manager

    hace 5 días

    Madrid, España Cmed A tiempo completo

    Why Cmed? Cmed occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials for immuno-oncology and cell & gene therapies, but also as a developer of its own technologies for managing clinical data. This is a very exciting time to join Cmed, as we continue to leverage our considerable...

  • Clinical Data Standards Expert: Designing Innovative Trials

    hace 2 semanas

    Madrid, Madrid, España Icon Clinical A tiempo completo

    **About ICON Clinical**ICON Clinical is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome talented professionals to join our mission.We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic...

  • Senior Clinical Trials Manager

    hace 2 semanas

    Madrid, Madrid, España Icon A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Clinical Trials Manager to join our team at Icon. This is an exciting opportunity for a motivated and experienced professional to lead clinical trials in a fast-paced environment.Job DescriptionThe Senior Clinical Trials Manager will be responsible for managing multiple clinical trials from start-up...

  • Clinical Operations Manager

    hace 1 mes

    Madrid, España Pharmiweb A tiempo completo

    Clinical Operations Manager Madrid Madrid, Community of Madrid, ES Are you a seasoned clinical research professional ready to lead and oversee ground breaking studies in cardiology and ALS?I am seeking dynamic and experienced Clinical Operations Managers to join my client a leading Global CRO and drive the success of global trials across Europe and...

  • Clinical Data Scientist

    hace 2 días

    Madrid, España Pivotal A tiempo completo

    .Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Data Scientist/Data Manager who shares our vision of providing clinical research excellence.Joining Pivotal as a Clinical Data Scientist/Data Manager , means that you will enjoy being a member of one of the leading full-service contract research...

  • Clinical Data Standards Expert

    hace 2 semanas

    Madrid, Madrid, España Icon Clinical Plc A tiempo completo

    Company Overview ICON Clinical Plc is a world-leading healthcare intelligence and clinical research organization, dedicated to fostering innovation and excellence in the industry. We pride ourselves on our inclusive environment, welcoming diverse talents to join us on our mission to shape the future of clinical development.">About the RoleWe are seeking a...

  • Clinical Operations Manager

    hace 4 semanas

    Madrid, España Pharmiweb A tiempo completo

    Clinical Operations ManagerMadridMadrid, Community of Madrid, ES Are you a seasoned clinical research professional ready to lead and oversee ground breaking studies in cardiology and ALS? I am seeking dynamic and experienced Clinical Operations Managers to join my client a leading Global CRO and drive the success of global trials across Europe and...