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Senior Clinical Project Manager

ClinChoice
Contract type
Ongoing
Work mode
Remote · Romania
Experience
Senior · 8+ years

Job description

A Senior Clinical Project Manager role at a global full-service CRO, leading cross-functional teams and overseeing the execution of complex clinical trials for pharmaceutical, biotechnology, medical device and consumer health clients. The position is a permanent remote opportunity based in Romania.

At a glance

Employment
Full-time · Employee (employment agreement)
Work mode
Remote · Romania
Languages
English – fluent

What you'll do

  • Manage and coordinate complex 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.
  • 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.

What we're looking for

  • 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.
  • Eight (8) years (at least) of clinical research experience in Project Management.
  • Previous experience managing respiratory, rare disease, general medicines and/or GPL1 studies is required.
  • Previous CRO experience is required.
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements.
  • Fluent in English.
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook).

Nice to have

  • Previous CRA experience is highly desirable.
  • Prior experience in electronic data capture preferred.

How to get hired

  1. 1Once you have submitted your CV, you will receive an acknowledgement that we received it.
  2. 2If you have the requirements we need, you will be invited for phone interview as the first step.

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About ClinChoice

Global full-service CRO

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.

Mission

To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices

Key facts

  • over 4,000 professionals
  • Contract Research Organization (CRO)
  • Over 28 years of proven high-quality delivery and results across all our services
  • Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
  • Recognized for its commitment to professional development, strong work-life balance, and a collaborative, quality-driven "one-team" culture
  • Below industry average turnover rates

What they value

  • Commitment to professional development
  • Strong work-life balance
  • Collaborative, quality-driven "one-team" culture
  • Diversity and inclusivity
  • Continuous training