Head of Clinical Data Management

Our client - an international company in the biopharmaceutical industry, is looking for a Head of Clinical Data Management.

Type of role: Permanent

Location: Basel

Job purpose

To lead and develop 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 postmarketing 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.

Duties and responsibilities

• To lead and develop the Data Management and Database Programming section and assume staff liability for the people employed in the section.

• To 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.

• To 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. 

Further Responsibilities

• 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. 

Main Assignments

Head of Data Management and Database Programming

To lead and develop the Data Management and Database Programming section including employees, internal and external consultants and the software and systems supporting the section in a way that ensures high quality of deliverables that meet the needs of the company, and adherence to current regulations and guidelines. 

Project Support 

To manage all (outsourced as well as in-house) database programming and data management activities i.e. evaluate CROs and vendors, database programming and data management activities in assigned clinical studies and follow-up services provided.  

Project Support - Database Programming

• Support the database programming aspect of the clinical projects, including programming of data review reports and regulatory documents.

• Support the setup, testing, maintenance and decommissioning of electronic systems used for study conduct, including general and study-specific documentation. 

Project Support - Data Management 

 • To work as a member of the Clinical Team to establish, communicate and deliver on a clinical data handling strategy and plan involving study start-up, conduct and close-out.

• To prepare and update clinical data management sections in Clinical Development Plans.

• To ensure the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan etc. 

• To ensure Clinical Data Management input to other relevant strategic study documents (i.e. study protocol,) and vendor contracts.

• Ensure that the appointed Clinical Research Organizations’ Standard Operating Procedures and Clinical Data Management processes are in agreement with regulatory and company requirements.

• Ensure data delivered to company is in accordance with regulatory requirements and company standards. 

Professional Qualifications

• 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..

Personal Qualifications

• 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.

• Ability to build talent and lead teams with influencing and development skills.

• Able to work under pressure in a changing environment with flexibility and proactivity.

• Willingness to travel up to 20%.

• Demonstrated ability to work independently.

• Demonstrated ability to work in a team environment.

• Demonstrated focus on details.

• Demonstrated ability to find innovative approaches and implement continuous improvement projects.

If you wish to apply, please send your most up-to-date CV to vyara@consortia-recruitment.ch