RHO

Manager, Study Start-Up

Job Location US
ID
2024-2962
Type
Regular Full-Time

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 Manager, Study Start-Up to join our team! In this role, you will lead and manage a study start up (SSU) team composed of SSU Leads and Associates that are responsible for the planning, coordination, and execution of all activities required to initiate clinical trials within a CRO setting. This role is crucial in overseeing the efficient and timely start-up of clinical studies, including feasibility assessments, regulatory document collection, ethics committee submissions, and contract negotiations. You will have the opportunity to collaborate closely with the Director, Global Feasibility and Study Start Up as well as other key internal stakeholders to achieve study start-up goals while maintaining compliance with regulatory requirements and company policies.

 

Our SSU 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 the primary line manager of the SSU team, including making project assignments, managing workload, providing technical guidance, and supporting professional development.
  • Ensure that the broader SSU team has the support needed to meet study start-up timelines and deliverables across multiple clinical studies.
  • Guide members of the SSU team in the development and execution of study start-up plans, ensuring alignment with the client and study requirements.
  • Oversee the performance and productivity of the SSU team, ensuring adherence to start-up budgets, SOPs, regulatory requirements, and study protocols.
  • Identify risks to key start-up milestones across multiple clinical trials, implementing mitigation strategies where applicable and escalating critical concerns as necessary.
  • Work with other members of SSU management and key start-up stakeholders to identify opportunities to streamline and improve study start-up processes, reducing timelines and increasing efficiency; lead initiatives to implement best practices and innovative solutions within the study start-up team.
  • Conduct quality checks on start-up deliverables to ensure accuracy and completeness.
  • Participate in sponsor and regulatory authority audits as requested by Quality Assurance (QA)
  • Work with Talent Acquisition and participates in candidate employee interviews
  • Participate in client presentations and/or bid defense meetings
  • Attend in-person meetings as required
  • Exhibit Rho’s Core Values at all times
  • Provide excellent customer service to internal and external clients in a timely and professional manner
  • Respond to email and other communication requests in a timely fashion using a variety of methods including but not limited to email, instant messaging and other communication tools

Qualifications

  • B.S. in life sciences, healthcare, or a related field and 7 years of clinical research experience inclusive of at least 4 years in a study start-up role or an equivalent combination of relevant and preferred education and/or work experience
  • Proven experience in managing teams and leading study start-up activities across multiple studies and therapeutic areas; excellent project management skills, with the ability to manage multiple priorities and meet tight deadlines; strong leadership and team management abilities, with a focus on mentoring and developing staff
  • Strong understanding of ICH-GCP guidelines, local and global regulatory requirements
  • Proficiency in MS Office and clinical trial management systems
  • Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s with the ability to build strong professional relationships
  • 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; we have ability to see patterns in issues, discount non-issues and prioritize to make progress
  • 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 $120,000 to $140,000 per year.

 

EOE. Veterans/Disabled

 

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