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.
As our next Clinical Project Manager II, you’ll have the opportunity to successfully plan, implement, and execute clinical trial projects of moderate size and complexity in compliance with Good Clinical Practices (GCP) and standard procedures agreed upon in each Sponsor contract.
You will also will be responsible for all team members throughout the clinical trial and may assist Project Management staff on larger, complex, or global projects.
This is a remote position within the US with the willingness to travel for sponsor visits, meetings and trainings, as needed.
Our Project Managers 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
- Act as project team leadership and manage cross-functional project teams and vendors
- Plan, implement, and oversee clinical trials from start-up through the final deliverable, ensuring all contractual expectations are met
- Build and maintain positive client relationships, and understand project level requirements and level of satisfaction with progress and performance, and recognize additional opportunities to expand business or scope;
provide timely and accurate performance feedback to team members and Directors, as appropriate
Maintain contact with project stakeholders to determine project requirements and level of satisfaction with progress and performance;
communicate clearly and effectively with the internal project teams and Sponsors; lead data review meetings to ensure timely review of clinical data with key stakeholders
Ensure the completion of set-up and maintenance of all project documentation files, internal databases, tracking systems, and project plans with project specific information;
coordinate and perform the QC of study reports and other project documentation
- Develop and maintain project management specific plans and reviews functional area plans
- Identify, evaluate, and manage project risks and study trends throughout the trial conduct with internal and external stakeholders and escalate, when appropriate;
Identify, define, document and ensure compliance with project specific training requirements
- Establish and manage project timelines and budgets, including appropriate budget / activity forecasting, tracking of out of scope activities, and ensuring budget adherence by internal and external team members
- Identify the need for and secures resources to assist other functional areas as needed;
- Develop presentation materials and presents at external meetings
- As appropriate, attend site visits with assigned monitor and may perform tasks including but not limited to : regulatory binder review, source document verification, site training, etc.
- Assure that all aspects of projects are performed in compliance with corporate standard operating procedures (SOPs), Sponsor SOPs (if applicable), Federal law, and ICH and Good Clinical Practices (GCP) guidelines, where applicable
- Contribute to the development and maintenance of functional area SOPs, guidance documents and forms; contributes to the evaluation of existing processes and tools and prepares new tools as needed
- Train new Project Management employees, including Research Associates
- Lead the effort with Contracts and Proposals and Business Development teams to support RFIs and RFPs, including participating in bid defenses
Qualifications
Bachelor's degree, preferably in life science area, or public health along with 5 years working in the clinical trials industry, which includes 2-3 years leading full-service projects and identifying and managing project risks;
experience with site operations and site management and understanding of protocol development and / or review; knowledge of drug development process and federal regulations.
- 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.
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(k).
All employees are eligible for paid time off, holidays, parental leave and bereavement leave.
Diversity and Inclusion : As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day.
By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.
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 $110,000-135,000 per year
EOE. Veterans / Disabled
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