Online Development Training Lead

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. 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 - Clinical Trials ?
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.
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.
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.
Perform other duties as assigned by management.
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

Fluency in English and for non-English speaking countries the local language of country where position is based.
Advanced degree in life sciences or related field
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
Excellent time management and prioritization skills to ensure deadlines are met.
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For government reporting purposes, we ask candidates to respond to the below self-identification survey.As set forth in Precision for Medicine’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.
As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. or a person who was discharged or released from active duty because of a service-connected disability.
S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
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