Ver oferta completa

SENIOR LEAD CLINICAL DATA MANAGER - EUROPE (HOME OR OFFICE BASED) - IQVIA BIOTECH

Descripción de la oferta de empleo

IQVIA Biotech is a unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced working environment. The sector we work in is cutting edge with therapies for un-met medical needIQVIA Biotech Offers Candidates Intensive Onboarding ProgrammesHome-based workingRegular line manager support and oversight ensuring good work/home life balance for proactive career development1000’s of online training sessions.Mentorship for all new startersBASIC FUNCTIONS:Senior Lead Clinical Data Manager position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:Manages DM-related aspects of the program and/or projectCollaborates with the project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiencyRepresent DM as the functional lead at internal and sponsor project team meetingsProvides proactive, timely communication of project status, data trends and issue resolution with internal team and SponsorDevelops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and SponsorAssumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projectionsDiscusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutionsPerforms peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studiesReviews and provides DM staffing projections for program and/or projectsPresents EDC and/or CRF completion at Investigator MeetingsParticipates in regulatory and Sponsor audits for program and/or projectsOversees daily team member activitiesServes as a Data Management team leaderReviews DM team member activities and deliverables to ensure plans and processes are followedAssures project activities are performed within budget and according to expected timelines and meet high quality standards.Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectivelyProvides training of DM staff on project specific processesOversees the DM project and/or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans including but not limited to:Discrepancy managementData Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendorsInvestigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviewAssumes ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures, coordinating with manager for resourcing requirements Oversees System Development and Modifications:Implements DM strategy on the project/program based on scope of services and as laid out by DM managementCoordinates with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM startup timelines including the development, testing and implementation of all data capture toolsCoordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelinesCoordinates with the Technical Design and Clinical Programming team and/or 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirementsCoordinates with the EDC programmers and/or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO), and electronic clinical reported outcomes (eCOA) as required per the scope of work. Facilitates project team and Sponsor reviews of system documents including but not limited to Time and Events Schedule, CRFs, Edit Checks, revision specificationsConsolidates reviewer comments from internal team/sponsor and collaborates with the project and Clinical Programming team, as required, for revisionsCoordinates with the project team as well as the Technical Design and Clinical programming team to manage post go-live EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and/or projectsOversees System and Data Listing Testing Activities:Coordinates testing activities for the EDC technologies per scope of servicesPerforms testing for EDC systems as required per scope of services and standard operating proceduresVerifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests Provides feedback to the other project team members and managers to improve the deliverables.Develops, Maintains and Archives DM Project Documentation including:Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as requiredData review listing specificationsDatabase Design Documents, Edit Specifications, Reconciliation guidelines, and Report specificationsDatabase lock documentationRepresents Data Management at Bid Defense Meetings (BDM)Prepares project-specific slide presentation from DM template functional slidesParticipates in BDM preparation meetings including discussing overall DM strategyPresents DM slides at BDM and constructively participates in discussionContinuous ImprovementRecommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templatesServes as Data Operations mentorCreates and maintain documentation for templates (DMP, CRF Completion guidelines, Database Design Documents, Edit specifications, Reconciliation guidelines, Report specifications)Trains others on specific departmental processes including database design document creation, edit check creation, change control processes, database lockProvides open environment for question/issues about DM topics from within department and cross-functionallyKNOWLEDGE, SKILLS AND ABILITIES:Team player with ability to learn new skills, tasks and technologies and teach othersAbility to collaborate and strategize with both technical and clinical team members (CRAs, Safety, Biostatistics, etc)Ability to effectively communicate technical issues to non-DM team members and SponsorAbility to maintain positive and open relations with internal, sponsor, and vendor team membersAbility to facilitate team meetings ensuring accurate attendees and take meeting minutesAbility to develop study-specific proceduresKnowledge of clinical trials conceptsAbility to create detailed DM project instructions and documents (CRF Completion Guidelines, Database design documents, edit check specifications, Data Review Plan, etc.)Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)Proficiency with IQVIA Biotech SOPs, WPsEfficient with organizational skills to meet established timelinesOrganized and thorough with attention to detailsExcellent verbal, written and listening communications skillsEffective interpersonal skills including ability to provide and accept constructive feedbackEffective logical thinking ability regarding problem-solving skillsProficiency in computer applications and time management tools (e.g., MS Office)MINIMUM RECRUITMENT STANDARDS:Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification7 years of experience in clinical trials within a similar function, including:proven competence in managing delivery of multiple projects / programs independently through full data management study life-cycleexperience in handling bid defense meetingsEquivalent combination of education, training and experienceAt IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
Ver oferta completa
No me interesa

Detalles de la oferta

Empresa
  • IQVIA
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Salario
  • Sin especificar
Fecha de publicación
  • 12/08/2021
Fecha de expiración
  • 10/11/2021
Office Manager
Hays

Managing office supplies... scheduling meetings and coordinating office hospitality... the company:retail multinational leader in its sectoryour new role:supporting the general manager and ensuring the smooth daily running of the ssc office... requisitos del puestothe company:retail multinational leader......

Office Manager
Hays

Managing office supplies... scheduling meetings and coordinating office hospitality... the company:retail multinational leader in its sectoryour new role:supporting the general manager and ensuring the smooth daily running of the ssc office... requisitos del puestothe company:retail multinational leader......

Office Manager
Hays

Managing office supplies... scheduling meetings and coordinating office hospitality... the company:retail multinational leader in its sectoryour new role:supporting the general manager and ensuring the smooth daily running of the ssc office... requisitos del puestothe company:retail multinational leader......

Office Manager
Arbolus Technologies

Create metrics that help us measure the success of the office management, and design and implement improvements as the office grows proactively follow up with internal stakeholders to gather and document feedback... based in london, we are a venture-backed scale-up with offices in barcelona (our largest)......

Office Manager
Hays

Nivel avanzado de ms office... hays response selecciona para agencia de publicidad y marketing a un/a office manager... requisitos del puestohays response selecciona para agencia de publicidad y marketing a un/a office manager... otros datos del puestohays response selecciona para agencia de publicidad......

Office Manager
Hays

Nivel avanzado de ms office... hays response selecciona para agencia de publicidad y marketing a un/a office manager... requisitos del puestohays response selecciona para agencia de publicidad y marketing a un/a office manager... otros datos del puestohays response selecciona para agencia de publicidad......

Office manager
Logistics company

Office location - peniscola... we are looking to hire an office manager to be responsible for the general operation of the office... work conditions: in the office 09... purchasing office supplies and equipment and maintaining proper stock levels... duties will involve: greeting visitors answering incoming......

Office Manager despacho
Hays

Qué necesitarás para encajar con el puestoexperiencia como secretario/a de dirección, executive assistant u office manager... tu nuevo puestobuscamos office manager para la apertura de nuevas oficinas en barcelona de un reconocido despacho de abogados internacional... coordinación con el personal de......

Office Manager despacho
Hays

Qué necesitarás para encajar con el puestoexperiencia como secretario/a de dirección, executive assistant u office manager... tu nuevo puestobuscamos office manager para la apertura de nuevas oficinas en barcelona de un reconocido despacho de abogados internacional... coordinación con el personal de......

Office Manager con Inglés
Page Personnel España

Nivel de inglés alto;manejo de paquete office... empresa del sector retail precisa incorporar una office manager con inglés para sus oficinas ubicadas en madrid capital... control de correo entrante y saliente... desarrollo profesional... requisitos del puestofunciones:gestión de agendas: organización......