Associate Director – Drug Safety
CTC Clinical Trial Consulting - Basel, BS

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Associate Director Drug Safety

Reference Number: 04-12-766-AD-W-JW

Type of placement: Permanent

Location: Switzerland, Basel

Main Responsibilities:
Performing clinical trial data coding activities according to the company’s standards and regulatory requirements

Ensuring correctness and consistency of coding

Informing and suggesting solutions to the Clinical Science Representative on coding related issues

Producing coding listings for each dictionary for review by the Clinical Science Representative

Interacting with the Clinical Science Representative and the Data Scientists (Data Managers) to improve the coding of allocated study(ies)

Advising in the choice of the medical /project specific dictionaries to be used

Representing the Clinical Data Coding Group at Clinical Trial Team meetings

Meeting study timelines in terms of coding activities

Providing training to Coding Specialist(s) if needed

Overseeing the work of Coding Specialist(s) to ensure correctness and consistency of coding within the dictionaries

Presenting Coding related topics at Clinical Trial Team, Investigators, and Monitors meetings

Forecasting coding group resource requirements

Planning, integrating and performing the migration of the standard dictionaries (MedDRA, WHO DD) in accordance with the regulatory requirements

Identifying and adapting to new technologies like eClinical Trials management; ensuring continuous process improvement and optimization

Supervising the maintenance, and also the creation of new quality documents to describe working processes evolving with new state of the art technologies, in line with applicable regulations (ICH-GCP)

Qualifications and Experience:
Recognized degree in medicine, pharmacy or related disciplines

Knowledge of coding principles and medical terms

Minimum 8 years experience in the pharmaceutical field/clinical research within a pharmaceutical company or a clinical research organization

In-depth knowledge of international clinical research regulations and requirements (e.g., ICH-GCP)

Sound knowledge of coding of clinical trial data

Ability to lead, coordinate and supervise the activities of Coding Specialist(s)

Good organizational and presentation skills

Fluent in both written and spoken English

Relevant working/residency permit or Swiss/EU-Citizenship required

Our offer:
A competitive salary and generous social benefits

The possibility for development and advancement

The innovative and stimulating atmosphere of a multicultural environment

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