Clinical Trial Project Director

Job Title: Clinical Trial Project Director

Job Number: 35447

Location: , 

Job Description

We are looking for an organized and detail-oriented professional to join our team as a Project Director. This role involves collaborating with multiple departments to ensure regulatory compliance and managing several projects to meet deadlines and objectives. Key responsibilities include coordinating with internal teams and external partners, such as vendors, suppliers, contractors, and senior leadership.

The ideal candidate thrives in a fast-paced setting, takes initiative in finding solutions, and can adapt to uncertainty. They are a proactive team player, focused on supporting overall team success. This position offers the chance to contribute to important product development initiatives while deepening your industry knowledge.

Responsibilities

Oversees daily coordination of activities, ensuring all responsibilities are met and providing regular updates on project progress.  

• Has experience managing the full clinical trial lifecycle within the medical device industry.
• Prepares clear communications and contributes to the design of new tasks and initiatives.
• Coordinates and conducts investigations to resolve data issues and reconcile discrepancies.
• Supports stakeholders in the implementation of new projects and expanded scopes of work.
• Assists in maintaining project timelines and participates in meetings with internal teams and clients.
• Prepares and submits required documents to relevant stakeholders.
• Identifies future business opportunities with existing and potential clients.
• Independently manages regular client check-ins.
• Maintains financial records for contracts and projects.
• Remains informed on relevant operational processes such as sample handling, data entry, and shipping when needed.
• Reviews and approves project documentation as required.
• Ensures action items are followed up and completed.
• Involved in resource planning and reporting project forecasts and actual outcomes.
• Tracks technical deliverables and provides updates on upcoming milestones.
• Communicates with key stakeholders to ensure accurate program information.
• Provides regular updates to Clinical Operations on critical data.
• Adheres to applicable regulations, company policies, and documentation requirements, including maintaining necessary training.
• Maintains a positive, proactive approach to responsibilities and takes on additional tasks as needed.

Required Skills

Education and Certification Requirements*

• Bachelor's degree or higher in life sciences, health sciences, nursing, or a related field.
• 1-4 years of clinical research experience in industry settings as a Clinical Project Manager (CPM).
• 8+ years of project management experience preferred.

Professional Work Experience

• Previous experience as a CPM in the industry, with equivalent knowledge and skills gained through education, training, or combined experience (approx. 8 years).
• Familiarity with internal SOPs, FDA/ICH guidelines, GCP, and regulatory compliance.
• Global experience in North America and Europe required.
• Line management experience for teams meeting time-sensitive objectives.
• Experience managing remote employees preferred.
• Experience with outsourcing and vendor management.
• Proficient in budget development, negotiation, forecasting, and finance processes.
• Experience leading large-scale change and process improvements in clinical trials or medical operations.
• Experience in the medical device industry strongly preferred.
• Relevant experience through internships, co-ops, or fellowships is a plus

Qualifications and Skills

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook) and Adobe Acrobat.
• Experience with clinical trial systems (TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO) preferred.
• Strong verbal and written communication skills for engaging with internal teams, management, and external partners.
• Skilled in delivering presentations.
• Proven ability to identify and resolve technical issues.
• Ability to learn and apply procedural documents effectively.
• Prior regulatory experience is a plus.
• Ability to maintain confidentiality in clinical settings.

Other Key Skills and Attributes

• Proven success in high-growth and dynamic environments.
• Demonstrated intellectual curiosity, innovation, and problem-solving with an entrepreneurial mindset.
• Ability to lead fast-paced projects with a sense of urgency and commitment to quality.
• Hands-on experience and expertise in relevant fields.
• Strong track record as a team player and collaborator in small teams.
• Highly organized and detail-oriented, with a passion for delivering high-quality results.
• Exceptional communication skills, with the ability to translate technical concepts into user-friendly formats.
• Highest standards of professionalism, integrity, and ethics.

Travel Requirements

• No regular travel required, but ability to travel as needed is necessary.