Senior Clinical Project Manager

Role Description

We are currently seeking 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. In this role, you will lead cross-functional teams and oversee the execution of complex clinical trials, ensuring successful delivery in accordance with contractual commitments, SOPs, ICH-GCP guidelines, and applicable regulatory requirements.

This is a permanent remote opportunity, with the potential for a hybrid work arrangement depending on location. Please note that you must have CRO experience to be considered.

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.

Qualifications

• Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred.
• Eight (8) years (at least) of clinical research experience in Project Management.
• Previous experience managing oncology and 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.
• Fluent in English.
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).

Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.