Study Start Up Lead

2 weeks ago

North, South Carolina, United States Precision Medicine Group Full time
Job Title: Study Start Up Lead

Join Precision Medicine Group as a Study Start Up Lead and take on a challenging role that requires expertise in global site start-up activities. As a key member of our team, you will be responsible for executing the site start-up strategy and planning, including managing and coordinating activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/MoH submissions, and delivery of quality IMP release packages.

Key Responsibilities:
  • Develop and execute an activation readiness strategy to enable oversight of site start-up delivery.
  • Coordinate, develop, and present critical path planning, including IRB/EC & CA/MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements, and Contract Execution.
  • Collaborate and communicate with stakeholders to secure input for milestone planning and alignment of operational goals to ensure timely delivery of site start-up activities.
  • Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start-up.
  • Partner closely with Functional Leaders and Site Start-up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
  • Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real-time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
  • Coordinate translations for documents required for submissions.
  • Maintain communication with other key functions participating in country start-up, including Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project-specific status and deliverables.
  • Act as SME for collection and maintenance of site-level critical path to IMP Release data points, such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts, and budget negotiation requirements that may be in place, as well as other start-up requirements for assigned country.
  • Support country or site-level activities start-up activities as needed.
  • Support development of country-specific Country Start-up summary and process flow, identifying timelines, risks, and success factors.
  • Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
  • Mentor staff on local study start-up regulations, submissions, internal procedures, and SSDL.
  • Interact with clients in proposal activities, including slide development and client presentation as required.
Requirements:
  • Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
  • 5 years or more in start-up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.
  • 2 years or more experience in project milestone management, managing resources, budgets, and coordinating team activities.
Preferred Qualifications:
  • Advanced degree in life sciences or related field.
Competencies:
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Ability to follow task-specific procedures, be attentive to detail, and place importance on accuracy of information.
  • Excellent organizational skills.
  • Ability to effectively interact with project teams and effectively communicate in English and the local language of the country where located.
  • Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
  • Must demonstrate excellent computer skills.
  • Excellent time management and prioritization skills to ensure deadlines are met.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
  • Occasional travel may be required.

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

Reasonable estimate of the current range: $106,400 - $159,600 USD

Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

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