Senior Clinical Project Manager - Oncology/Respiratory

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house German team as a Senior Clinical Project Manager. You will work on projects from our varied client base, ranging from small to big pharmaceutical, biotechnology, medical device and consumer health companies.

 

As Senior Clinical Project Manager you will be responsible for leading cross-functional teams and managing complex projects. You will also ensure quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations. Previous experience working with a CRO, managing oncology and/or respiratory trials is required. This role is a full-time, remote opportunity. 

Join our global team and help improve peoples' lives! 

 

Main Job Tasks and Responsibilities:

• 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.
• Inform the Project Director/Leader about any issues.
• Perform co-monitoring visits for the assigned clinical projects as necessary.
• Act as a tutor for Project Coordinators and Project Manager I.
• Maintain relationships with the Sponsor, including providing project updates.
• Prepare the SOPs relating to clinical research activities in collaboration with the Quality System Unit.
• Collaborate in complying and enforcing Company procedures.

Education, Experience and Skills:

• 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 oncology and/or respiratory 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.