Start Up Specialist

The Start Up (SU) Specialist is an experienced professional in site start-up activities. Responsibilities will 
be dependent upon the location of the SU Specialist according to the applicable regulations and 
processes governing study and site start-up and activation readiness. Typically, these include activities 
such as Informed Consent Form review and adaptation, Essential Document collection and quality 
review, Support to Regulatory and sites on IRB/EC/CA submissions and support to Site Contracts group 
in budget and contract negotiation. The SU Specialist may act as Subject Matter Expert for questions by 
other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to 
development or revision 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: 
• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the 
assigned country/sites and foreseeing and mitigating any risks.
• Preparation/Support of EC/IRB submissions, collection and review of essential documents, notifications 
to IRB, EC and regulatory authorities, as appropriate.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and 
essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for 
submission.
• 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.
• When required, participate/support the negotiation of study budgets and the execution of investigator 
contracts under directions of Site Contract Management department/designee department.
• May support Regulatory group on research of local requirements for documentation of CA submissions, 
approvals, and subsequent follow-up documentation.
• May participate/support feasibility group in site outreach to assess potential interest of investigators to 
a potential study.
• May support process improvement, training and mentoring.
• Performs other duties as assigned by management.

Minimum Required:
• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination 
of education, training, and experience.
• 1 year or more as a SU specialist or comparable role in either a CRO or pharmaceutical/ biotech industry 
or equivalent, relevant experience and/or demonstrated competencies.
Other Required:
• Strong 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.
Preferred:
• Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular 
country.
• Experience using milestone tracking tools/systems
• Ability to prioritize workload to meet deadlines.

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.
• Strong 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.
• Good communication, presentation, interpersonal skills, both written and spoken, with an aptitude to 
learn how to inform, influence, convince, and persuade.
• Occasional travel may be required.