Specific Location: Lugano
Job Title: Lead Clinical Data Manager
Type of Job: Permanent
The Clinical Data Manager is the primary point of contact for the assigned studies and is responsible to conduct oversight of data management activities resulting in quality and accuracy of the clinical database. S/he is responsible to define, plan, coordinate and monitor all activities pertaining to the management of clinical data carried out by third parties with the goal of the product registration and maintenance of post-licensure of the product.
Provide independent leadership for assigned studies and act as primary liaison with CROs and the study team for data management activities. Provide regular status reports to the Head of DM as required, communicate potential risk factors in a timely and appropriate manner.
Provide input to protocol design.
Review the study budget and timelines for data management activities throughout the life cycle of the assigned studies.
Coordinate and supervise data management activities to ensure that study deliverables are achieved on time and to the highest quality, in compliance with international standards and guidelines, as well as Helsinn standards.
Support and supervise the development and quality reviews of key study documents such as the Case Report Form, CRF Completion Guidelines, Data Management Plan, Data Validation Specifications, Data Management Report, Study Specific Procedures and Forms, and other documents, as required, in compliance with Helsinn standards.
Support and supervise the development, integration and validation of the clinical database and other electronic systems. Perform User Acceptance Testing.
Support and supervise all data processing, data reconciliation, query generation and resolution, cleaning, medical coding, quality review tasks, database lock, and relevant archiving of study materials.
Review the clinical data collected throughout the conduct of the study in order to ensure that data cleaning activities are carried out by the CRO consistently and thoroughly.
Support blind data review meetings activities.
Support preparation of files and documentation for electronic submission to regulatory agencies.
Contribute to departmental SOP and process development and improvement, and integration of technology.
Minimum 7 years of operational experiences and technical expertise in data management department of a pharmaceutical company or in a CRO.
Level of Education:
Bachelor’s degree in a scientific discipline or equivalent.
The technical skills are specific to the data management/pharmaceutical field and guide the operational component of the position.
Basic knowledge of SAS system and technology platforms to capture and process data is required.
Knowledge of current industry standards such as CDISC (SDTM and CDASH) is required.
Knowledge of GCP, ICH and regulatory authorities’ guidelines as applicable for Clinical Data Management.
Demonstrated proficiency managing the lifecycle of clinical data projects.
Analytical and problem-solving skills, accuracy, and synthesis are required.
Ability to work independently and with the team.
Ability to interact with external consultants and CROs as well as with all other business functions.
Knowledge of English language is essential, so as the informatics tools.
Willingness to travel and also availability to travel outside the usual place of work, namely outside Company’s headquarters.
Closing Date: March 31, 2022
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