Study Start-Up Lead

2 tygodni temu

Warszawa, Mazovia, Polska Rho, Inc. Pełny etat
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 Study Start Up Lead to join our team in Europe As a Study Start Up Lead, you will have the opportunity to advance study start-up and regulatory activities by understanding client objectives. You will be in a key role in the developing the study plan for country and site activation. You will also manage and perform the start up and maintenance function, including the preparation, review, and overall management of submissions to ethics committee. Additionally, you will serve as the contact point for client matters related to study start-up and communicate issues effectively to client, clinical team and related study staff. Please note that you will be assigned to one or more start-up projects and works independently on a project with minimal to no supervision.

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
  • Manage the study start up process through site activation, working with Project Manager and Clinical Trial Lead to ensure timely site activations; develop country/site-specific startup timelines and strategies and oversee startup activities in the country
  • Participate in Sponsor meetings with respect to study start up, including endorsement of the SSU Operational Targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics
  • Partner closely with both Functional Leads and SSU Team Members to proactively identify study start up related issues
  • Ensure that relevant systems are maintained and up to date to analyze study start-up progress metrics against targets/timelines (at a project/country/site level)
  • Provide operational oversight to SSU Associates on assigned projects
  • Coordinate and develop the Start Up approach for IRB/EC approval at specified regional levels, including country level approval, and provide oversight of specific activities from SSU Team Members
  • Overall responsible for all submissions and obtaining approval from IRB/ECs (incl CTIS Part 2 package); may be responsible for submissions to Regulatory Authorities in non-EU countries (ex. UK, Georgia, South Africa etc)
  • Facilitate cooperation between cross-functional teams regarding startup activities; coordinate feasibility efforts and work together with Clinical Team Leads on site identification; in addition, partner with Clinical Team Leads and the client to identify requirements for the Site Initiation Visit (SIV) and Site Activation
  • Identify the Site Essential Document (SED) packet elements required, agree with relevant internal staff, track the completion and upload of documents, and communicate with all parties (e.g., Sponsor, Site Staff, Internal Staff) the status of documents; participate as the SED Reviewer as necessary
  • Coordinate the informed consent form (ICF) development, including the review, negotiation and approval with relevant internal and external parties
  • Support business development with proposal preparation and review and bid defense efforts
  • Coordinate site budget development, including the review, negotiation and approval with relevant internal and external parties.
  • Coordinate site contract negotiation process
Qualifications
  • At least 4 years of industry experience, which includes at least 2+ years of study start up leading experience or equivalent (global experience preferred)
  • Demonstrated ability in the leadership of a team of individuals in study start-up
  • Knowledge of applicable international regulatory requirements and guidelines (i.e., ICH-GCP, and/ or EU-Directives), as well as strong knowledge of Regulatory and Central/Local ethic submission processes for assigned countries
  • Strategic and creative risk management and contingency planning
  • Proficient computer and internet skills, including working knowledge of MS-office applications, such as MS Outlook, Word and Excel
  • Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho's. Fluency in both English and local languages.
  • 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.
  • Expected required travel 10% on average

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, and generous 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.

Please submit your resume/CV in English.

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#LI-JR1

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