ECRON ACUNOVA

Centerwatch

Position

Project Manager

Roles and Responsibilities

Managing of clinical trials including
- Attainment of agreements with sponsor regarding execution of projects
- Planning of clinical trials as regards contents, regulatory compliance and administrative and logistic aspects
- Interface management
- Management and co-ordination of CRAs:
  - Coordination of individual steps of national or multinational multicentre trials
  - Supervision of GCP compliance (e.g. giving "green light" for study initiation)
  - Supervision of the ongoing clinical part of a trial, as regards monitoring, safety aspects, timelines, and costs
  - Supervision of study termination
- Prospective troubleshooting (e.g. communication of relevant issues turning up during the clinical part and respective decisions in a timely manner to all relevant parties)
Transmission of information and discussion of the course of the project with the sponsor/DCO (Director Clinical Operations)
Cooperation with data management, biometrician and medical writing, medical services and pharmacovigilance, quality assurance, training
Participation in in-house inspections and/or audits (internal and external)
Responding to audit/inspection reports
Establishment of CAPA as applicable

Requirements

Experience in clinical research (preferably in a CRO)
A natural science degree or a pharmaceutical or medical degree is of advantage
At least one year experience in planning, conducting, supervising and evaluating clinical trials
The ability to think analytically and a talent for organising are required
Ability to comprehend regulatory structures and procedures
Ability to make oneself familiar with specific medical issues (e.g. study indications, symptoms, and methods for assessment of clinical parameters)
Understanding of biometrical hypotheses/strategies
Very good command of written and spoken English
Excellent organisational skills and team leading skills

Location

Medical Manager

Roles and Responsibilities

Requirements

Degree and license to practice medicine
Extensive medical knowledge and very good knowledge of internal medicine and pharmacology
Experience in conducting clinical studies
Very good command of written and spoken English
Experienced in MS office (Word and Excel)
High motivation and team-oriented
Good communication skills, dedication, reliability and a talent for organising are required

Location

Clinical Data Manager

Roles and Responsibilities

Requirements

Excellent knowledge of Oracle Clinical
Experience in clinical research
Well grounded with medical terminology and current coding thesauri (MedDRA, WHO-DD)
Profound experience in SAS would be highly advantageous
Good command of written and spoken English is required
Minimum of 3 years of professional experience
Experience in project management is of advantage

Location

Business Development Manager

Roles and Responsibilities

Requirements

Study of medicine, veterinary medicine, or natural science (understanding of medical matters required) is a plus
Practical experience in planning, conducting, supervising and evaluating clinical trials
Profound experience in the field of business development; optimally, in a CRO or central laboratory
Excellent knowledge of the pharmaceutical market,
Preferably contacts with decision makers at pharmaceutical companies
Very good command of written and spoken English (able to conduct negotiations)
Excellent communication skills

Location

Project Assistant

Roles and Responsibilities

Compilation, maintenance and supervision of Excel documents to control a project

Requirements

Location

Senior Clinical Research Associate

Roles and Responsibilities

To maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines
To provide assistance, where directed by the Project Manager, in specific tasks relating to the preparation of national and international projects
Co-ordination of CRAs and individual steps of national or multinational multicentre trials
Quality Control of monitoring functions and supervision of GCP compliance as well as time lines
Preparation and implementation of project meetings and investigators’ meetings
Training on the job for new CRAs and Project Assistants

Requirements

At least 2.5 Yrs of established experience as a CRA
Study of natural science (biology, chemistry), medicine, pharmacy or qualification as medical documentalist, health care specialist, paramedic professional
Excellent command of native language
Good command of written and spoken English
Willingness to travel extensively
The ability of a good communication, dedication, reliability and a talent for organising are required
Excellent organisational skills and team leading skills

Location

Clinical Research Associate

Roles and Responsibilities

To provide assistance, where directed by the Project Manager, in specific tasks relating to the preparation of the project (e.g. preparation of protocols; icf, preparation of planning documents).
To maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines.
To make regular contact with investigators or other site staff members during the course of studies, to ensure everything is proceeding to agreed protocols and time schedules, and the data is recorded accurately.
To review all data produced from each study and resolve any data queries/protocol deviations identified.
To provide a report, as required, of status of each of the studies for which he/she is responsible, and make any necessary recommendations for contingency planning.
To maintain effective communication with other members of the clinical team and management.

Requirements

B.Pharm/M.Pharm/M.Sc (Life sciences) with 1-2 Yrs experience as CRA in a reputed CRO dealing with Clinical Trials.
Training in GCP.
Relevant exp. in conducting multi-centric Clinical Trials.
Knowledge of processing & reporting AE/SAE events

Location