Start Up Lead

Precision for Medicine is a Clinical Research Organization. Precisions 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.

As our company continues we grow we are seeking a Site Start Up Lead to join our growing team. Location : Based in Australia/Singapore/South Korea/Taiwan.

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.

Qualifications:
Minimum Required:
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 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.

Other Required:
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 based.
Experience using milestone tracking tools/systems

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured impacting positive change for the company.

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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.

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 .

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