Head of Clinical Data Management

Head of Clinical Data Management

Sobi

Basel or Stockholm

Sobi is currently seeking an experienced Head of Clinical Data Management. The selected candidate will be responsible for leading and developing the Clinical Data Management section and ensure that all aspects of clinical data management and database programming, in all phases of development as well as in post-marketing activities, are of high quality and meet the needs of the company and regulatory agencies. To facilitate the provision of Clinical Data Management and Database Programming support to the Clinical Team in all phases of projects related to clinical development programs.

Key responsibilities

  • Lead and develop the Data Management and Database Programming section and assume staff liability for the people employed in the section;
  • Define policies and procedures within Data Management and Database Programming to ensure compliance with good clinical data management practices, regulatory guidelines, industry practices, and corporate and divisional governance;
  • Assume responsibility and system ownership of the Clinical Data Management System;
  • Manage use of external consultants to ensure appropriate level of project support;
  • Collaboration in BDM leadership team to ensure resources are efficiently utilized and resource gaps are identified and escalated to senior management when appropriate.
  • Develop and track timelines to ensure data management milestones are met in coordination with the Clinical Team;
  • Ensure database programming and clinical data management support in studies and projects as required;
  • Increase functional effectiveness by supporting departmental efforts to simplify and standardize procedures, sharing best practices and participating in or leading continuous improvement efforts;
  • Facilitate and/or participate in management and functional area meetings, contributing expertise when necessary through formal or informal presentations.
  • As part of the Biostatistics, Data Management and Medical Writing Leadership Team, provide input to Senior Management in the development and budgeting for the department;
  • Provide support to Senior Management in setting objectives and lead the Clinical Data Management team to achieve the business goals;
  • Train staff on business processes, operations and tools and supervise direct reports to ensure corporate and regulatory compliance;
  • Stay current on process and technology changes across the industry that may impact staff and business performance;
  • Lead and/or participates in initiatives beyond Clinical Data Management (e.g. cross-divisional projects, cross-industry initiatives etc.);
  • Function as section representative in audits and regulatory inspections.

Skills and Competencies

  • University degree (MSc or PhD) in Life Sciences, Computer Science or related discipline;
  • At least 8 years of experience in Clinical trials, preferably in Clinical Data Management;
  • Knowledge of end-to-end clinical development process;
  • Experience working with External Service Providers in the area of outsourced clinical studies;
  • Extensive experience in clinical research and development and in good clinical data management practices;
  • Sound understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training;
  • Fluency in English (oral and written);
  • Strong leadership and mentoring skills;
  • Strong organizational, communication, project management, decision-making, problem-solving and negotiation skills;
  • Ability to establish effective personal relationships across a wide range of business contacts;
  • Strong influencing and development skills, ability to build talent and lead teams;
  • Able to work under pressure in a changing environment with flexibility and proactivity;
  • Demonstrated ability to work independently and in a team environment;
  • Ability to focus on details;
  • Demonstrated ability to find innovative approaches and implement continuous improvement projects;
  • Willingness to travel up to 20%.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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