Descrizione dell'offerta
Site Start Up Lead APAC
Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry‑leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.
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 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. The Lead acts as a subject matter expert for questions by other in‑country members, trains less‑experienced staff, and may own country‑specific tools and guidance documents to increase knowledge sharing.
Essential Functions
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 align 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 maintain systems 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 key functions participating in country start‑up (feasibility, clinical operations, project management, regulatory and site contracts management) 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/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.
Directly support country or site‑level activities when needed.
Develop country‑specific country start‑up summary and process flow identifying timelines, risks, and success factors.
Facilitate training sessions to expand country start‑up knowledge and serve as SME 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.
Qualifications
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 experience, ideally with SU Lead or PM experience in a CRO or pharmaceutical/biotech industry, or equivalent, with relevant experience and/or demonstrated competencies.
2 years or more experience in project milestone management, managing resources, budgets, and coordinating team activities.
Demonstrated leadership experience in driving cross‑functional activities.
Excellent communication and organizational skills.
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
Fluency in English and, for non‑English speaking countries, the local language of the country where the position is based.
Experience using milestone tracking tools/systems.
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.
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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 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. The Lead acts as a subject matter expert for questions by other in‑country members, trains less‑experienced staff, and may own country‑specific tools and guidance documents to increase knowledge sharing.
Essential Functions
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 align 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 maintain systems 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 key functions participating in country start‑up (feasibility, clinical operations, project management, regulatory and site contracts management) 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/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.
Directly support country or site‑level activities when needed.
Develop country‑specific country start‑up summary and process flow identifying timelines, risks, and success factors.
Facilitate training sessions to expand country start‑up knowledge and serve as SME 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.
Qualifications
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 experience, ideally with SU Lead or PM experience in a CRO or pharmaceutical/biotech industry, or equivalent, with relevant experience and/or demonstrated competencies.
2 years or more experience in project milestone management, managing resources, budgets, and coordinating team activities.
Demonstrated leadership experience in driving cross‑functional activities.
Excellent communication and organizational skills.
Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail.
Fluency in English and, for non‑English speaking countries, the local language of the country where the position is based.
Experience using milestone tracking tools/systems.
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.
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