Senior Clinical Data Manager

hace 2 semanas

Madrid, España Precision Medicine Group 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 will also oversee and/or perform database development and testing. Essential functions of the job include but are not limited to: Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing May perform quality control of data entry Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders May assist in building clinical databases Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. Review and query clinical trial data according to the Data Management Plan Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM Run patient and study level status and metric reporting Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency Coordinate SAE/AE reconciliation Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables May assist with SAS programming and quality control of SAS programs used in the Data Management department Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings May review Request for Proposals (RFP), proposals, provide project estimates Provide leadership for cross-functional and organization-wide initiatives, where applicable Trains and ensures that all data management project team members have been sufficiently trained Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues May present software demonstrations/trainings, department/company training sessions, present at project meetings May require some travel Perform other duties as assigned Qualifications: Minimum Required: Bachelors and/or a combination of related experience Other Required: 8+ years' experience Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook Able to handle a variety of clinical research tasks Excellent organizational and communication skills Professional use of the English language; both written and oral Experience in utilizing various clinical database management systems Broad knowledge of drug, device and/or biologic development and effective data management practices Strong representational skills, ability to communicate effectively orally and in writing Strong leadership and interpersonal skills Ability to undertake occasional travel Preferred: Experience in a clinical, scientific or healthcare discipline Dictionary medical coding (MedDRA and WHODrug) Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…) Oncology and/or Orphan Drug therapeutic experience #J-18808-Ljbffr

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, Madrid, España Precision For Medicine A tiempo completo

    Job Summary:The Senior Clinical Data Manager plays a key role in overseeing the clinical trial data management process for assigned projects, ensuring compliance with Standard Operating Procedures, regulatory guidelines, and study plans. Responsibilities include managing database development and testing, serving as the primary point of contact for data...

  • Senior Clinical Data Science Lead

    hace 2 semanas

    Madrid, España Icon Clinical Plc A tiempo completo

    .ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center of all that we do, we help to accelerate the development...

  • Senior Clinical Data Manager

    hace 1 mes

    Madrid, España Precisionscientia 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 will...

  • Senior Clinical Data Manager

    hace 1 mes

    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 will...

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, 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 will...

  • Senior Clinical Data Science Lead

    hace 2 semanas

    Madrid, España Icon Clinical Plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center of all that we do, we help to accelerate the development...

  • Senior Clinical Data Manager

    hace 1 mes

    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 will...

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, 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 will...

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, España Precision Medicine Group 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 will...

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, España Jr Spain A tiempo completo

    col-wideJob Description: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...

  • Senior Clinical Data Manager

    hace 2 semanas

    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...

  • Senior Clinical Data Manager

    hace 2 semanas

    Madrid, España Precision Medicine Group 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 will...

  • (Senior) Clinical Project Manager

    hace 2 semanas

    Madrid, España Icon Clinical Plc A tiempo completo

    .(Senior) Clinical Project Manager - Oncology Madrid, Community of Madrid (Senior) Clinical Project Manager - OncologyMadridMadrid, Community of Madrid, ES At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It'...

  • Senior Clinical Data Manager I

    hace 2 semanas

    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...

  • Senior Clinical Data Manager

    hace 1 mes

    Madrid, España MAI Fortrea Development Limited A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Data Manager

    hace 3 semanas

    Madrid, España Oxford Global Resources A tiempo completo

    **Clinical Data Manager**: - Location: Madrid, Spain - Contact: Susagna Sastre Magem - Job type: Temp to Perm - Industry: Pharmaceutical, Life Sciences, Management Consulting, Clinical Research - Oxford Global Resources is looking for a Clinical Data Management who will have to perform all aspects of data management to ensure our client located in Madrid...

  • Senior Clinical Data Manager

    hace 10 horas

    Madrid, España Mai Fortrea Development Limited A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.With over 19,000 staff...

  • Senior Clinical Trial Manager

    hace 2 semanas

    Madrid, España Allergan A tiempo completo

    .Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...

  • Clinical Trial Manager

    hace 2 semanas

    Madrid, Madrid, España Al Solutions A tiempo completo

    Clinical Trial Manager Start up CROSpain.Taylor Young is working with a Start-up CRO that is looking for a Clinical Trial Manager to join a highly experienced clinical operations team in Spain.My client has very strong core values which results in a great work environment and very happy staffThis role is working remotely in Poland. This is a unique...

  • Senior Clinical Trial Manager

    hace 2 semanas

    Madrid, España Abbvie A tiempo completo

    .Area of Interest: Analytical Research & DevelopmentTravel: NoCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology,...