Clinical Project Manager

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Project Manager who shares our vision of providing clinical research excellence. Joining Pivotal as a Project Manager means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed to medical science while using technology to make a positive impact.
• We provide an exceptional experience and take care of our employees, ensuring everyone receives permanent mentoring and training.
• We are continuously building the company, bringing together diversity of thoughts, backgrounds, cultures, and perspectives.

Position summary:

Project Manager (PM) is responsible for coordinating a team of Lead Clinical Research Associates (LCRAs), and/or Clinical Research Associates (CRAs), assisting in training and mentoring. PM is the contact person for the Sponsor in all monitoring and project management activities and will be responsible for maintaining timelines, ensuring compliance with regulatory standards, and delivering projects within scope, on time, and within budget. PMs may be based at Pivotal’s Office or home-based.

Your responsibilities will include:

• Define project objectives, deliverables, and timelines in collaboration with clients and other team members.
• Develop detailed project plans, including risk management.
• Act as the primary point of contact for clients, ensuring effective communication and relationship management throughout the project lifecycle.
• Address client concerns, provide project updates, and ensure client expectations are met or exceeded.
• Lead and manage cross-functional teams (regulatory, data management, biostatistics, pharmacovigilance, quality assurance) to execute project deliverables.
• Coordinate activities across departments, ensuring alignment with project goals and timelines.
• Track project timelines, milestones, and deliverables, ensuring adherence to established deadlines.
• Proactively manage any deviations from the project plan and implement corrective actions as needed.
• Identify project risks and develop mitigation strategies.
• Resolve issues that may arise during the course of the project and escalate unresolved problems to senior management as appropriate.
• Ensure all project activities comply with regulatory requirements (e.g., GCP, FDA, EMA) and corresponding SOPs and quality standards.
• Maintain comprehensive project documentation, including status reports, meeting minutes, and project updates.

Requirements:

• University Degree in life science or other scientific discipline in health care.
• Master course in Clinical Research Trials is highly recommended.
• A minimum of 3 years of experience in clinical research as LCRA or similar position at a CRO, Pharmaceutical Company or other related institutions.
• Sound knowledge of GCPs/ICH and national/international regulations is desirable.
• Experience in monitoring, site coordination and management of people is recommended.
• Availability to travel a minimum of 40% of working time.

Skills:

• Demonstrated problem-solving skills, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures.
• Strong written and verbal communication skills, attention to detail and ability to work in a fast-paced environment.
• Ability to work autonomously.
• Fluency in English.
• Good knowledge of Office (Word, Excel and PowerPoint).

What you can expect:

• Resources that promote your career growth.
• Leaders that support flexible work schedules.
• Trainings to help you build your therapeutic knowledge.
• Dynamic work environments that expose you to new experiences.

Commitment to Equal Opportunity

At Pivotal, we believe that diversity and inclusion are essential to the success of our team. We are committed to providing equal employment opportunities to all candidates, regardless of race, gender, sexual orientation, disability, or any other characteristic.