Oferty pracy: clinical data management

Are you an experienced Clinical Project Manager who's engaged in addressing the challenges facing the research and development of novel compounds. 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 are looking to hire a (Senior) Project Manager to manage clinical studies for one of our dedicated clients, ideally with experience in Nephrology, Immunology and/or Autoimmune Disease.

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

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:

• 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.
• Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
• Liaise with Project Team and senior management of both Precision and sponsors, including C level
• Handle and lead all aspects of a clinical research trial or trials
• Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
• Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
• Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
• Prepare and reviews protocols and other study documentation such as project plans, inform 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 or client dedicated (FSP) model/global Project Management role working in the CRO industry is essential.
• 5 to 7 years industry experience and at least 4 years Project Management experience in a clinical trial setting working for a Clinical Research Organisation.
• Experience managing studies within Nephrology, Immunology and/or Autoimmune Disease.
• 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 individual 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

Precision for Medicine's 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.

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.