Company Description
PSI is a leading Contract Research Organization with more than 27 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
Only CVs in English will be considered
In this position, you will be responsible for coordinating activities of project teams ensuring milestones are met and ensuring consistency of Clinical Operations processes. This function holds project managerial responsibilities under supervision.
Responsibilities will include:
- Coordinating project team work, supervising the clinical project team members’ performance,
- Implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents,
- Acting as a point of contact for the project team, PSI support services and contractors,
- Collecting and reporting project status updates,
- Developing and updating project planning documents, essential study documents and project manuals/ instructions,
- Conducting and supervising therapeutic area training of the project team and Investigators,
- Supervising preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits and reviewing site visit reports,
- Overseeing investigator and site payments,
- Supervising project team preparation for study audits/inspections and resolution of audit/inspection findings,
- Coordinating preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications,
- Performing other project management tasks in agreement with the responsible Clinical Operations Manager following adequate and documented training, and formal delegation of tasks.
Qualifications
- College/University degree in Life Sciences or an equivalent combination of education, training & experience,
- Full working proficiency in Portuguese and English,
- At least 4 years’ experience in a health care or clinical environment,
- Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor or equivalent,
- Availability to travel,
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
Additional Information
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
Top Skills
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
