Precision for Medicine is looking for an Associate Start Up Lead to join our team. The position could be covered fully remotely from Serbia, Romania, Hungary, Slovakia or Poland.
Position Summary:
The Associate Start Up Lead is experienced in driving country and/or regional 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 delivery of quality IMP release packages. The Associate Start Up Lead may also
have global exposure to CA/ MoH submissions. Will act as Subject Matter Expert for questions by other
in-country members (RSSs, CRAs, PSSs or others) supporting site start-up activities, may support
development 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 (if
assigned to global study), 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.
• May 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.
• Performs other duties as assigned by management.
Minimum Required:
• Bachelor's degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination
of education, training, and experience.
• 3 years or more in start-up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/
biotech industry.
• 1 year or more experience in project milestone management, managing resources, budgets and
coordinating team activities.
• 1 year or more experience presenting to clients.
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.
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
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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.
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