Clinical Team Lead Ii
hace 1 semana
Overview:
Join us in redefining what it means to work for a CRO.
Working at Rho, you'll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity's biggest challenges.
At Rho, we're committed to you just as you're committed to us.You'll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.
With a collaborative team of smart, talented, and positive people, you'll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.
We are currently hiring a Clinical Team Lead II to join our team The Clinical Team Lead is integral to driving project success.
In addition, you'll be responsible for the oversight of all operational aspects related to the planning and management of CRA and site performance.
You'll ensure that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and local Regulations.Our Clinical Operations Team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group
Responsibilities:
- Proactively drive project success, including working closely with Project Managers to develop and implement enrollment strategies
- Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations
- Develop monitoring tools and plans
- Determine and drive the study start up process (track and report progress, review data), ensuring that all sites are selected and supplies provided in accordance with study start expectations
- Provide skilled review of study protocols and other study materials (e.g. CRF)
- Monitor clinical operations timelines, metrics, resourcing, budget and activities
- Provide status updates to project management and sponsors
- Lead regular clinical team teleconferences
- Work effectively with Site Study Coordinators
- Participate in the RFP process, including internal and external business development meetings
- Review monitoring visit reports and ensure finalization is within contractual timeline
- May assist Project Managers with project management tasks as assigned
- Create and conduct training sessions including investigator meetings, conferences, and team trainings
- Support the management and development of other CRAs
- Participate in the Clinical Operations community at Rho by leading key internal initiatives and standard operating procedures for the administration and monitoring the clinical trials
Qualifications:
- 8+ years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry, including 2 years of experience leading the clinical operations function within clinical trials and at least 2 years of onsite monitoring experience; preferred therapeutic experience in CNS, Rare Disease, Pain, or Respiratory
- BA/BS, preferably in a life science, nursing, pharmacy or related field
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho's.
- Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our highquality scientific standards, and an ability to care about every outcome.
- High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
- Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
- Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.
- Ability to travel, as needed, possibly up to 25%
A few more things to know about us:
Benefits:
Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401
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