Project Manager/Senior Project Manager - Clinical Trials

Precision Medicine Group; United States; Remote; USD 75,000 - 115,000; Full time

Job summary

An established industry player is seeking an experienced Project Manager to oversee clinical trials in Oncology and Rare Diseases. This pivotal role involves managing all aspects of clinical projects, ensuring successful delivery while collaborating with internal and external stakeholders. As a key contributor, you will navigate the complexities of trial management, from proposal strategy to project completion, all while fostering a supportive and dynamic team environment. If you're passionate about making a difference in patients' lives and thrive in a collaborative setting, this opportunity is perfect for you.

Benefits

Flexible Work Hours

Professional Development Opportunities

Health and Wellness Programs

Collaborative Team Environment

Qualifications

• 5-7 years of industry experience, with at least 3 years in full service Project Management.
• Strong understanding of GCP/ICH guidelines and clinical development processes.

Responsibilities

• Lead clinical projects, ensuring timelines, scope, and quality are met.
• Serve as primary liaison with clients, providing excellent customer service.

Skills

Project Management

Clinical Trials Management

Interpersonal Skills

Presentation Skills

Medical Terminology

Education

Degree in Life Sciences

Equivalent Combination of Education and Experience

Tools

MS Office

MS Project

PowerPoint

CTMS

eTMF

EDC

IXRS

Job description

Are you an experienced full service Project Manager in the field of clinical trials who’s engaged in addressing the challenges facing the research and development of novel compounds in Oncology, Rare Disease or CNS? Are you passionate about impacting the health and lives of patients around the world? Do you take a consultative approach to trial management, proving to be a valuable partner in trial operational delivery?

Precision for Medicine (CRO) are looking to hire an experienced Project Manager ideally with experience in ONCOLOGY and/or RARE DISEASES or CNS who have managed full service clinical trials within a CRO setting to join our global team.

We can offer a Project Manager or Senior Project Manager position depending on level of experience. We can consider candidates living in the following countries: Poland, Hungary, Romania, Slovakia, Serbia, UK or Spain.

In this pivotal role you will have full service oversight for clinical projects across global/regional (ph I-IV) trials, within Oncology (or Rare Diseases or CNS). Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.

Involved in all study stages, including proposal strategy, development, costing, and bid defence, and seeing studies through the full cycle to completion, managing the client relationship, project team and budget and timelines throughout.

You will work in a cross-functional team with both internal and external stakeholders, driving quality and coordinating the study team.

Precision for Medicine is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

We are a people focussed CRO with a supportive and collaborative environment which promotes work life balance and encourages team development.

We invite you to learn more about our growing organization serving our clients that are researching ground-breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day.

We offer an amazing high-energy, dedicated, collaborative team members who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and seek positive teamwork to deliver extraordinary work, we have an opportunity for you.

How we will keep you busy and support your growth:

1. You will independently lead clinical projects in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives. You may be called upon to run international trials as well.
2. Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations.
3. Liaise with Project Team and senior management of both Precision and sponsors, including C level.
4. Handle and lead all aspects of a clinical research trial or trials.
5. Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
6. Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
7. Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials.
8. Prepare and review protocols and other study documentation such as project plans, informed consents, site contracts and budgets.

Requirements:

• Degree or similar related life science qualification, or equivalent combination of education and experience.
• Previous experience in a full service/global Project Management role working in the CRO industry is essential.
• 5 to 7 years industry experience and at least 3 years full service Project Management experience in a clinical trial setting working for a Clinical Research Organisation.
• Working understanding of GCP/ICH guidelines and the clinical development process.
• Ability to drive and availability for domestic and international travel including overnight stays.
• Be able to communicate effectively in the English language both written and spoken.
• Strong presentation skills.
• Proven computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS).
• Proven ability to develop positive working relationships with individuals and teams internally and externally.
• Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan.