Clinical Data Lead

Date: 05-Aug-2022

Location: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

Company: Almirall

Mission

Based on best international practices, capture, integrate and store clinical trials information (data and documents) to allow on-going data analysis and results reporting to access efficiently  to clinical data of our medicinal products and to allow a shorter decision making process.

Tasks & Responsibilities

•    This Job is responsible for performing the necessary internal processes and overviewing CRO activities for adherence to the applicable data standards, quality and timelines, following Good Clinical Data Management Practices and applicable Clinical Trials Regulations, like FDA, EMA, ICH.
•    These responsibilities apply to all clinical trials sponsored by Almirall.
•    Collaboration in the selection of the Contract Research Organizations (CROs).
•    Coordination of the calendar and processes of data management activities of the clinical trials with the rest of Jobs of the Clinical Study Team.
•    Review of the protocol for adherence to Almirall Data Management processes and Data Standards.
•    Lead  the review and approval of the Case Report Form (CRF)  or electronic Case Report Form (eCRF) and its corresponding completion guidelines. 
•    Lead the review and approval of the annotated documents and study metadata for adherence to applicable standards.
•    Management of any data finding or/and processes during trial conduction that implies changes in the standards/processes. Being aligned with the responsible lead of coordination these standards.
•    To provide guidance for the expected Regulatory documentation needed for the study.

•    Responsible for the management of the database activities (overall supervision and main contact for Data Management (DM) activities):

•    Set-up: Review annotated documents, study metadata, trial definition domain, Data Management Plan (coding, validation plan, SAE reconciliation between safety and clinical databases) vendor’s technical specifications (from DM perspective)
•    Conduct: Manage with the CRO to have data available for data visualization and analysis at the agreed milestones established at contract level. Assessment of  the database structure and study documentation review, evaluation of the data quality in on-going basis. Coordination of Almirall data review activities and follow-up or finding resolution with CRO.

•    Closure: Management of the database lock processes ,  review related database lock documentation (including approval of coding and SAE reconciliation), evaluation of the database quality (minimum requirements) before database lock approval to warrantee Almirall requirements.
•    Provision to CROs of the necessary documentation to perform the outsourced activities according to Almirall standards processes and expectations.
•    Follow-up on target and metrics indicators for overseeing quality and deliverables of CRO Data Management activities.

Education

Bachelor degree in Statistics, Mathematics, Life and Health Science (Pharmacy, Veterinary, Medicine, Biology), IT or Degree with specific experience in the Job.

Experience

•    Coordination of cross-functional teams.
•    Knowledgeable of programming language SAS.
•    Clinical trial experience.
•    English is essential.
•    2+ years as Clinical Data Lead or Data Manager in pharma industry or CRO.
•    Project Management and planning experience is required.

Values and competencies

  • Caring
  • Dedicated
  • Dynamic
  • Expert.