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.
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
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.
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
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 pertinent and various therapeutic areas, medical terminology, and clinical trial activities as it relates to the execution of a clinical development plan
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
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.