Associate Start up Lead

Precision for Medicine

Serbia, Romania, Hungary, Slovakia or PolandFull-TimeLead

Salary not disclosed

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Job Details

Languages: English, local language of country where position based
Experience: 3 years or more in start-up, 1 year or more experience in project milestone management, 1 year or more experience presenting to clients

Requirements

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.
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.
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.

Responsibilities

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.
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.
Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.

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