What are the responsibilities and job description for the Join our Talent Community- Clinical Trial Manager position at Precision for Medicine?

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

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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