Clinical Trials Start Up Lead

Company: Precision Medicine Group
Location: Gladstone
Posted on: April 18, 2024

Job Description:

Clinical Trials Start Up Lead
at Precision Medicine Group (View all jobs)
Remote, United States

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages-from early development through approval-with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won't you join us today as a Start Up Lead?

Position Summary:
The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination 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. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of 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 to allow on time activation.
• 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.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., 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.
• If needed, directly support country or site level activities start up activities.
• 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.
• Perform other duties as assigned by management.
  Qualifications:
  
  • Bachelors 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, with SU Lead or PM experience managing multiple countries in either a CRO or pharmaceutical/biotech industry
    Other:
    
    • Demonstrated leadership experience in driving cross-functional activities
    • Excellent communication and organizational skills are essential.
    • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail required.
    • Fluency in English and for non-English speaking countries the local language of country where position is based.
    • Experience using milestone tracking tools/systems
      Preferred:
      
      • 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 team(s) 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 is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
          
          Reasonable estimate of the current range
          
          $113,000 - $152,800 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 .
          
          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. - 2020 Precision Medicine Group, LLC
          
          If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .

Keywords: Precision Medicine Group, Union , Clinical Trials Start Up Lead, Healthcare , Gladstone, New Jersey