Job Description
We are a team of clinical trial experts who are dedicated to the success of our clients so that patients can receive much-needed treatments. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first, where the quality of our work is the best, and where our employees can thrive while still having fun and giving back to the patient community. We are very proud of the Clinical Trial Management team at Precision for Medicine and what it has achieved thus far. Are you ready to be part of a close-knit clinical trial team that is passionate about saving and improving the lives of patients every single day? Then look no further, we’d like to help you take your career to the next level.
You will lead and manage the clinical team on a study in regards to timeline adherence and project scope while ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details, and flourish in dynamic environments to explore this opportunity. If you are no stranger to taking charge and seek positive partnerships to deliver phenomenal work, we have an opportunity for you.
About You:
You have a passion for bringing lifesaving and lifealtering treatments to market
You love having responsibility and a say in how clinical trials are run
You plan ahead but have alternative options in case things go wrong
Last minute requests and shifting priorities don't rattle you
You are extraordinary at handling study timelines while never sacrificing quality
You communicate clearly, often, and concisely and know that your role is crucial in keeping the trial running smoothly
You are a master at identifying any risks that threaten projects and handle them resolutely
You thrive with minimal direction and happily take responsibility for the outcomes of your work
You are a team player and thrive working in a collaborative environment
About the CTM Role:
Management and operational delivery of the clinical elements within a trial, including site feasibility and selection, start-up, clinical plans and document development, subject enrollment, site engagement and support, monitoring planning and execution, resourcing, regulatory documentation, data cleaning activities, and close-out
Successful execution of assigned trials and ensuring completion of trial deliverables
Ensuring appropriate communication and ongoing oversight of assigned trial(s) by working in close collaboration with the sponsor and other functional team members
Participation in and presentation at sponsor meetings, including bid defenses, kick-off meetings, investigator meetings, and face-to-face meetings
Mentoring and training team members
Identifying challenges to study timelines/deliverables and offering creative action plans to the team/sponsor
Leading CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, and overall site correspondence activities
Contribute to company and department initiatives to grow and strengthen processes, procedures, and the PFM overall
Qualifications:
Minimum Required:
Bachelor’s degree or equivalent combination of education/experience in science or health-related field
Clinical Trial Lead/Manager: Minimum of 5 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Prefer at least 2 years of CTM experience at a CRO, Pharma or Biotech company.
Senior Clinical Trial Lead/Manager: Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Prefer at least 4 years of CTM experience at a CRO, Pharma or Biotech company.
Other Required:
Moderate independent field monitoring experience
Clinical team lead or comparable supervisory experience
Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Experience with various EDC a ... (truncated, view full listing at source)