Senior Clinical Project Manager
at ClinChoice (View all jobs) United States
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 team as a Senior Clinical Project Manager to join their internal team in the United States. 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 managing the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH-GCP guidelines and other applicable regulations.

Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
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.
• Organise and participate in Monitor and Investigator Meetings.
• Organise 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:

• University Degree in scientific, medical, or paramedical disciplines.
• Proven experience in clinical project management activities within the CRO/pharmaceutical industry, including previous experience as a CRA or similar.
• Excellent 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 acknowledgement that we received it. If you have the requirements we need, you will be invited for 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.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
Our Company Ethos
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. The success of these core values is evidenced by our below industry average turnover rates.

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.
Key words: Senior Project Manager, Clinical Project Manager, Senior Study Manager, Study Management Associate, Project Management Associate, Clinical, Medical Devices, Clinical Trial Management, Clinical Trial Manager, Clinical Study Manager, Study Management, Project Leader, Project Lead, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated