O pozici
ClinChoice is a global full-service CRO recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven “one-team” culture. We are currently recruiting for a Senior Clinical Project Manager to support projects across pharmaceutical, biotechnology, medical device, and consumer health clients, ranging from emerging companies to large global organizations.
Co budeš dělat
- Manage and coordinate the assigned clinical projects.
- Manage all project specific services required by the Sponsor (central lab exams, drug shipments, document shipments, etc.).
- Manage the correct development of the clinical project, interacting with the Sponsor and the Investigators and properly coordinating the project team members.
- Keep professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned.
- Knowledgeable in the application process for clinical studies, in force in the country/ies of work.
- Collect and manage study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.).
- May act as a Technical Specialist supervising the projects within specific therapeutic and technical areas.
- Assure the proper timelines of the assigned projects.
- Manage the budget for the project.
- Monitor the workload and the performance of the project team.
- Plan and monitor the tasks of the team in the specific areas.
- Coordinate the Clinical Research Associates and Clinical Monitors activity.
- Collaborate with the Clinical Trial Administrators and Clinical Research Associates in terms of local authorities approval activities.
- Collaborate in the overall management of the project with the assigned Biometrics team and with all other project team members involved in the delivery of specific activities (such as Safety, Regulatory, etc.).
- Collaborate with the CTAs in archiving activities.
- Assist the Medical Monitor in preparing protocols, Case Report Forms, and final Clinical Study Reports.
- Deliver project specific trainings.
- Organize and participate in Monitor and Investigator Meetings.
- Organize or take part in the periodic project update meetings.
- Provide project updates to the Sponsor, Senior Project Manager and Project Director/Leader as required.
Koho hledáme
- Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- Eight (8) years (at least) of clinical research experience in Project Management.
- Previous experience managing hematology/oncology studies is required.
- Previous CRA experience is highly desirable.
- Previous CRO experience is required.
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
- Prior experience in electronic data capture preferred.
- Fluent in English.
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).
Benefity
- global full-service CRO recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven “one-team” culture.
- permanent remote opportunity, with potential hybrid arrangement depending on location
- Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
- Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel.
- The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.
- Our Company Ethos: ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
