Itec services

Jobs

ITEC SERVICES careers: your skills and personal qualities are essential to us.

Jobs in a scientific sector, men and women working in teams on the same project, ethical management based on respect for the individual; and, if you wish, responsibility to further your career.

Clinical research associate
Data manager
Data processor
Clinical study manager & Epidemiological study manager
Project leader

CLINICAL RESEARCH ASSOCIATE

Qualifications:

• Science Bac+4, other subjects Bac+5, CRA Diploma, or higher (physician, pharmacist…), or equivalent qualifications
• Professional experience:
  0 to 2 years => Junior CRA
  2 years or more => Senior CRA
• Good knowledge of English
• Computer and internet skills

Relevant personal attributes:

• Meticulous
• Methodical and organised
• Social skills
• Professional enthusiasm
• Leadership
• Mobility
• Practical know-how
• Physical stamina (business travel)

Description and Responsibilities:

• Inaugurates, follows-up, and finally closes investigation sites. Helps investigators throughout a study, explains the protocol, clarifies difficulties, and helps with practical organisation;
• Monitors study progress, checks investigators’ compliance with GCP and relevant regulatory procedures;
• Checks source documents, helps investigators to manage documentation;
• Arranges medical supplies, with investigators or hospital pharmacists, checks that supplementary examinations are performed according to the protocol;
• Writes a report after each site visit and telephone contact, to keep the Project Leader informed;
• Verifies, ‘in-house’, case report forms (CRFs) data and checks for missing or incorrect data to be corrected at the next site visit;
• Helps data transfer with masks generated by Data Management, or the Sponsor, and requests appropriate corrections.

Career development:

Long-term

• Quality Control Manager
• Project Leader

Other fields

• Data management (?)

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DATA MANAGER

Qualifications:

• Science Bac+4, other subjects Bac+5, DM Diploma (or higher), or equivalent qualifications
• Professional experience:
  0 to 2 years => Junior DM
  2 years or more =>Senior DM
• Good knowledge of English
• Excellent computer skills

Relevant personal attributes:

• Meticulous
• Methodical and organised
• Social skills
• Job enthusiasm
• Leadership

Description and Responsibilities:

• Designs and sets up database structures for clinical and pharmacovigilance studies, and tailors them to case report forms;
• Ensures that databases of different studies are consistent within a project and comply with quality standards;
• Creates management systems to operate databases, prepares freezing of databases and subsequent locking;
• Ensures that projects progress according to the plan agreed with the Sponsor/Contractor, and takes correctives steps as necessary, informs about hold-ups and anticipates them, if possible;
• Coordinates activities of data processing staff;
• Takes responsibility for operational and technical aspects of the database, planning, and resources (human and material) required by a project.

Career development:

Long-term

• Director of Data Management
• Computer Systems Manager

Other fields

• Quality control

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DATA PROCESSOR

Qualifications:

• Minimum: BAC or equivalent
• Good computer skills

Relevant personal attributes:

• Meticulous
• Fast learner
• Motivation
• Speed and dexterity

Description and Responsibilities:

• Transfers data from case report forms;
• Tracks problems encountered during data transfer and reports them to the Data Manager;
• Is responsible for the accuracy of data capture (i.e., conformity with CRF, adherence to data handling guidelines);
• Follows data control plan.
  A Data Processor is responsible for the accuracy of data capture (i.e., conformity with CRF, adherence to data handling guidelines).

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CLINICAL STUDY MANAGER & EPIDEMIOLOGICAL STUDY MANAGER

Qualifications:

• Science Bac+4, other subjects Bac+4, DM Diploma or higher, or equivalent qualification
• Professional experience:
  5 years or more => Assistant Manager
• Good command of English
• Excellent computer skills

Relevant personal attributes:

• Meticulous
• Methodical and organised
• Good interpersonal skills
• Sound grasp of procedures
• Leadership

Description and Responsibilities:

• Supports Project Leader in planning and managing administrative tasks for a successful outcome;
• Initiates corrective and preventitive procedures;
• Manages study secretaries;
• Controls study action plan;
• Helps with CRF design;
• Distributes and tracks investigator brochures, memos, consent forms, protocols, amendments, case report forms, and patient diaries, with the internal project team and investigators (via filing system);
• Checks distribution and tracking of confidentiality agreements and protocol summaries, verifies that investigator CVs are in-house;
• Initiates regulatory procedures and declarations, controlled by Project Leader collaborating with the Sponsor;
• Prepares and distributes information and confidentiality agreements to hospitals and pharmacies associated with candidate centres;
• Helps Project Leader with feasibility studies;
• Plans the logistics of investigator meetings;
• Organises study documents;
• Deals with telephone calls concerning projects, when Project Leader is absent or unavailable.
  The Study Manager is responsible for ensuring that the above tasks are performed successfully and reports to the Project Leader. The job is key to avoiding delays or errors.

Career development:

Long-term

• Clinical Research Associate

Other fields

• Quality control

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PROJECT LEADER

Qualifications:

• Physician or pharmacist, or Bac+5 with successful record in Project Management
• Professional experience: Minimum 10 years
• Fluent English
• Good computer skills
• Sound understanding of procedures

Relevant personal attributes:

• Meticulous
• Methodical and organised
• Good listener
• Analytical mind
• Leadership

Description and Responsibilities:

• Organises meetings with principal investigators representing the project in different regions;
• Defines personnel and materials required for projects;
• Prepares documents for Ethics Committee submissions and tracks the review process to obtain approval with minimum delay;
• Prepares authorisation requests to Ministry of Health so that the study can start as soon as possible;
• Ensures that pharmacies or importers can supply investigators;
• Checks contacts with investigator about supplies (storage, dispensing, follow-up documentation…) to avoid shortages;
• Reviews examination requests per patient to up-date cost estimates, checks results and invoices, follow-up…;
• Manages CRAs;
• Monitors and checks site visit reports;
• Ensures follow-up of pharmacovigilance events…
  The Project Leader is at the interface with Sponsor on all technical aspects of a study. Resolution of logistical, planning and coordination problems are crucial to the success of a project and are the Project Leader’s primary concern.

Career development:

Long-term

• Quality Control Manager
• Clinical Trial Director

Other fields

• Pharmacovigilance

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