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EDETEK Inc.
EDETEK Inc.
201 – 500 Angajați
BiotehnologieProduse farmaceuticeSaaS
EDETEK Inc. dezvoltă software și servicii de informatică clinică pentru organizații din domeniul farmaceutic, biotehnologic și al dispozitivelor medicale. Ecosistemul său de cercetare și dezvoltare, construit nativ pentru cloud, reunește o platformă eClinical pentru gestionarea studiilor clinice și pregătirea dosarelor de reglementare, cu instrumente pentru coordonarea studiilor, gestionarea studiilor clinice (CTMS), captarea electronică a datelor clinice (EDC), raportarea electronică a rezultatelor și evaluărilor de către pacienți (ePRO/eCOA), gestionarea randomizării și a aprovizionării studiilor (RTSM), integrarea datelor, gestionarea metadatelor și calculul statistic. Compania oferă și servicii de biostatistică și programare, gestionare a datelor clinice, dezvoltare a studiilor, redactare medicală și operațiuni eClinical. EDETEK se concentrează pe conectarea datelor clinice și susținerea calității acestora pe întregul ciclu de viață al studiului, platforma incluzând și funcționalități bazate pe inteligență artificială.
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Remote Clinical Data Management Manager

Lead clinical data management delivery for EDETEK’s CONFORM eClinical implementations and clinical trial projects. Oversee client coordination, user acceptance testing, documentation, and development of junior team members.

USStatele Unite ale AmericiiRemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică

Descriere

  • Lead the clinical data management team.
  • Maintain project management documentation.
  • Deliver clinical data management work and implement EDETEK’s CONFORM eClinical system.
  • Develop design specifications for system forms, reports, and related components.
  • Coordinate testing for system implementations.
  • Manage data management projects to meet quality standards and deadlines while maintaining client satisfaction.
  • Assess client needs and develop project solutions using relevant expertise, operational resources, and technology.
  • Communicate with clients and internal teams.
  • Contribute to internal clinical data management initiatives.
  • Carry out routine and assigned data management operations.
  • Discuss client requirements and issues, uphold standard operating procedures, and track project progress and timelines.
  • Help develop and maintain systems that support project infrastructure.
  • Work with Clinical Data Specialists to carry out Data Management Plans.
  • Coordinate with clients and sponsors to deliver contracted clinical data management services with quality and integrity.
  • Ensure required documents are filed according to EDETEK and project requirements.
  • Lead user acceptance testing for new software.
  • Select and interview clinical data manager candidates.
  • Train and mentor junior team members.

Cerințe

  • Communicate effectively in English in person, by phone, and in writing.
  • Lead functional meetings.
  • Maintain strong attention to detail and accuracy.
  • Demonstrate excellent organizational skills.
  • Manage multiple projects effectively.
  • Work collaboratively and productively across diverse organizational structures.
  • Work independently, take initiative, and meet deadlines while demonstrating excellence, customer service, accountability, ownership, and cross-functional communication.
  • Contribute effectively in a team-oriented, collaborative environment.
  • Adapt positively to ongoing change.
  • Prioritize and complete work effectively in a high-pressure environment.
  • Use computers proficiently, including Microsoft Office and potentially project management software.
  • Hold a bachelor’s degree or an equivalent combination of education, training, and experience; a scientific, medical, or technology degree is preferred.
  • Have at least two years of clinical trial, clinical data management, or comparable industry experience or training.
  • Prior responsibility for the full trial data management lifecycle is desirable.
  • Have working knowledge of EDC studies and SAS.
  • Work in a corporate office environment.
  • Be available for occasional travel, up to 5%, potentially including weekends.
  • Collaborate across functions.

Beneficii

  • Choice of comprehensive medical, vision, and dental insurance plans.
  • Paid vacation and sick leave.
  • Annual corporate holidays.
  • Participation in the 401(k) plan.
  • Perks and discounts covering AAA, wholesale, insurance, prescriptions, fitness, pets, entertainment, and more.
  • Health Advocate and Employee Assistance Program.

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