Start Up Lead

Precision AQ; United States; Remoto; USD 92.000 - 137.000; Tempo pieno

Vantaggi offerti da questo lavoro

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Descrizione del lavoro

precision medicine group, llc is seeking a Start Up Lead to oversee global site start-up activities, including ICF customization, IRB/EC and MoH submissions, and delivery of IMP release packages. You will act as SME and trainer for in-country staff and may own country-specific tools.

Responsibilities include developing activation readiness strategies, critical path planning, coordinating with stakeholders, risk mitigation, and ensuring timely site activation while maintaining real-time progress

Competenze

• Bachelor's degree in life sciences or RN or equivalent
• 5+ years in start-up, ideally SU Lead or PM experience in CRO/pharma/biotech
• 2+ years in project milestone management, resources, budgets, and coordinating teams

Mansioni

• Manage site start-up process with activation readiness strategy
• Coordinate critical path planning for IRB/EC & CA/MoH, ICF customization, risk mitigations
• Collaborate with stakeholders to align milestones and deliverables
• Participate in client meetings to set expectations and report progress
• Partner with functional leaders to mitigate risks and keep timelines
• Ensure tracking systems reflect progress at study, country, and site levels
• Co-ordinate translations for submissions
• Maintain communication with Feasibility, Clinical Operations and Regulatory groups
• Act as SME for country start-up data collection and IMP release data points
• Support country/site start-up activities when needed
• Develop country start-up summaries and process flows
• Facilitate trainings to expand country start-up knowledge
• Mentor staff on regulations, submissions, and procedures
• Interact with clients in proposal and presentations
• Perform other duties as assigned by management

Conoscenze

Demonstrated leadership experience

Excellent communication

Organizational skills

Experience using milestone tracking

Formazione

Bachelor's degree in life sciences

Registered Nurse (RN)

Strumenti

Milestone tracking tools

Descrizione del lavoro

Location: Remote, United States
Category: Clinical Trial Services
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 7348

Position Summary:

TheStart Up (SU)Leadis an expertinglobalsite start-up activitiesandis accountablefor the execution of thesitestart-up strategy and planning, including the management and coordination activities such asCore/Site document collectionandapproval, ICF customizationandapproval,IRB/EC andCA/ MoH submissionsand delivery ofquality IMP release packages.Will act asSubject Matter Expert for questions by other in-country members (SUSs,CRAs, CSSs or others) supporting site start-up activities,Trainer forless-experienced staff on site start-up activitiesand may be identifiedasOwner 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 anactivation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning includingIRB/EC &CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicatewith stakeholdersto secure input for milestoneplanning, and alignment of operationalgoalsto ensure timely delivery ofsitestart up activitiesto allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metricsrelated tositestart up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to deliveryanddevelop and executemitigationsto removerisks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systemsare maintainedin real timetoallow analysis ofprogress metrics against targets/timelinesat study,country,and site levels.
• Responsibletoco-ordinatetranslations 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 ofsite level critical path toIMP Releasedatapointssuch aslocal IRB/Ethics Committee (EC)timelines, otherrequired reviewsto secure activation, site contracts and budget negotiationrequirements that maybe in place as well asother 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 developmentand facilitationof 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 proceduresand SSDL.
• Interact with clientsin proposal activities, includingslidedevelopment and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

• Bachelorsdegreein life sciences or related field,or RegisteredNurse (RN)or equivalent combination of education,training,and experience.
• 5years or moreinstart up, ideallywithSU Lead orPMexperiencein 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.

Other Required:

• Demonstrated leadership experienceindriving 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 based.
• Experience usingmilestonetracking tools/systems

Preferred:

• Advanced degreein life sciences or related field
• 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.
• Excellentorganizational 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.
• 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

$91,500— $137,300 USD

Candidates must be legally authorized to work in the country of employment without employer sponsorship.

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 [e-mail] .