Job Abstract

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 and eTMF systems
• Excellent communication and interpersonal skills to effectively interface with others in a team setting
• Excellent organizational skills, attention to detail, and a customer service demeanor
• Availability for domestic and international travel, including overnight stays

Skills:

• Demonstrated computer skills (MS Office, M PowerPoint, etc.) and software experience (CTMS, eTMF, EDC, IXRS, RTSM, etc.)
• Demonstrated ability to develop positive working relationships with internal and external organizations
• Demonstrated core understanding of pertientent and various therapeutic areas, medical terminology, and clinical trial activities as it relates to the execution of a clinical development plan

Competencies:

Including, but not limited to:

• Demonstrates mastery knowledge of ICH-GCP, and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
• Results-oriented, accountable, motivated, and flexible
• Excellent time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills
• Direct work experience in a cross-functional environment
• Excellent presentation, verbal, and written communications skills
• In-depth proven experience in pharmaceutical and/or device research required