Clinical Trial Lead/Manager and Senior Clinical Trial Lead/Manager
Location: Carlsbad, California US
Job Id: 2898
Position Title: Senior Manager, Clinical Operations & Manager, Clinical Operations
Who are we?
Precision for Medicine, Oncology & Rare Disease is not your typical CRO. We are a team of clinical trial experts who are dedicated to the success of our clients, so that ultimately patients can receive much-needed treatments. We believe our success is much more about what it does every single day and how it does it, than about its revenues. 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 Rare Disease 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 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 protocol and site level in regards to timeline adherence and 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.
We are addressing the challenges facing the research and development of novel compounds in Rare Diseases and are dedicated to positively impacting the health and lives of patients around the world. If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don't miss exploring working with us.
- You have a passion for bringing lifesaving and life altering 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
How we will keep you busy and support your growth:
- Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, regulatory documentation, data cleaning activities and close-out
- Successful execution of assigned trials and ensuring completion of trial deliverables
- Ensure appropriate communication and ongoing oversight of assigned trial(s) by working in close collaboration with the sponsor and other functional team members
- Mentor and train team members
- Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor
- Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities
- Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction
Senior Clinical Trial Leads/Managers are responsible for the independent clinical project delivery for small studies without an allocated Project Manager.
Minimum Required: Bachelor’s degree or equivalent combination of education/experience in science or health-related field
Clinical Trial Lead/Manager: · 5+ years relevant experience, to include the demonstrated ability to provide guidance and direction to others effectively and/or demonstrated experience in clinical study management, monitoring, and in developing study-related documents.
Senior Clinical Trial Lead/Manager: · 8+ year’s relevant experience, inclusive of 1-2 years directly managing others effectively and/or effective clinical study management, monitoring, and in developing study-related documents.
- 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, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
- Demonstrated ability to develop positive working relationships with internal and external organizations
- Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
- Demonstrates mastery knowledge of ICH-GCP, meaningful Precision for Medicine’s SOPs, and regulatory guidance, as well as the ability to implement
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. © 2018 Precision Medicine Group, LLC
Division: Precision For Medicine
Business Unit: Oncology & Rare Disease
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
Country: United States
Community / Marketing Title: Clinical Trial Lead/Manager and Senior Clinical Trial Lead/Manager
Country: United States
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
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.
Location_formattedLocationLong: Carlsbad, California US