Location: Poland - Home based
Schedule: Freelance, Various FTEs
CROMSOURCE is a growing international CRO dedicated to a quality-focused approach with a collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Freelance Clinical Project Manager I, to join their clinical operations team in Poland. This is a full-time opportunity. You will work on projects from our varied client base, ranging from small to mid-sized pharma and medical device companies.
As a Project Manager, you will be responsible, for oversight of assigned clinical projects ensuring the quality of services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines, and other, applicable regulations. You may also act as Project Director/Leader, depending on the complexity of the projects.
Join our team and help us deliver clinical trials that will improve patients' lives.
Main Tasks and Responsibilities:
- Manages the development and planning of clinical projects, interacting with the Sponsor and the Investigators and coordinating the project team member
- Oversees the application process for clinical studies, in force in the country(ies) of work. Verifies the assigned project activities plan and timelines and the related critical state
- Manages the budget of the project
- Participates in Monitor's and Investigator's Meetings
- Provides project updates to the Sponsor and to the Project Director/Leader and to the Clinical Department Director; participates in update meetings.
- Informs Project Director/Leader and the Clinical Department Director about any issues that can jeopardize the business relationship with the Sponsor
- Supervises the team in relation to monitoring including submissions, site visits, ensuring compliance with ICH/GCP guidelines and applicable laws and regulations
- Undertakes workload and performance assessments of the project team working with the Clinical Research Department Director to ensure adequate support levels
- May provide oversight and mentoring for junior staff assigned to the projects.
- Supervises the archiving activities
- Supervises, in the overall management of the project, the assigned Biometrics team and all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc…)
- Assists the Medical Monitor (MEM) in preparing protocols, Case Report Forms (CRFs), and final Clinical Study Reports (CSRs)
- Performs, if necessary, co-monitoring visits for the assigned clinical projects
- May act as Feasibility Associate (FEA) after appropriate and documented training
- May prepare SOPs relating to clinical research activities in collaboration with the Quality System Unit (QSU)
- Arranges and collaborate with the assigned Clinical Research Department Director, in identifying the project-specific training of the project team and in delivering them
- Education and Experience:
- University Degree in scientific, medical, or paramedical disciplines
- Up to three 3 years of project management experience in the CRO/Pharmaceutical industry
- Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements
- Fluent in English and local language(s)
- Proficiency in Microsoft Office (e.g., Word, Excel, Outlook)
- Willingness to travel
The Application Process
Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.
If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact firstname.lastname@example.org for more information.
Who will you be working for?
CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Drugs, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Clinical Study Management, Project Leader, Project Lead, CRO, Clinical Research Organisation, Contract Research Organisation
Clinical Project Manager, Clinical Study Manager, clinical trials, ICH-GCP, Project Management, English