We are currently hiring a Clinical Team Lead to join our team! As Clinical Team Lead II, you are integral in driving clinical research project success. You will have the opportunity to independently manage and maintain ownership of the clinical operations portion of assigned projects. You'll provide direction to and training CRAs assigned to those projects. In addition, you will oversee of all operational aspects related to the planning and oversight of CRA and site performance as well as ensuring that sites and CRAs operate in compliance with study protocols, ICH/GCP guidelines, and Federal Regulations.
This role can be remote anywhere in the US.
What You'll Be Doing:
- Proactively drive project success, including working closely with cross-functional study leadership to develop and implement operational strategies
- Identify and mitigate clinical risks, as well as contribute to the development of the quality risk management plan
- Provide skilled review of study protocols and other study materials (e.g. CRF)
- Develop and manage clinical operations timelines, metrics, resourcing, budget and activities
- Develop monitoring tools and plans
- Accountable for operational aspects of planning and oversight of site performance in accordance with departmental productivity expectations
- Create and conduct training sessions including investigator meetings, conferences, and team trainings
- 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 expectations
- Provide status updates to project management and sponsors
- Lead regular clinical team teleconferences
- Work effectively with Site staff, as needed, serving as an escalation point for CRAs as issues arise
- Manage clinical Site communication and documentation of decisions, including mass correspondence to sites regarding study updates
- 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
- Support the management and development of In-house CRAs and CRAs
Requirements- 8+ years of clinical research experience within the CRO, pharmaceutical, or biotechnology industry, including 1-2 years of experience leading the clinical operations function within clinical trials and at least 2 years of on-site monitoring experience; preferred therapeutic experience in Neurology and Pain.
- 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 high-quality 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%
BenefitsA 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(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.
As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $130,000-$150,000 per year.
