Study Start-up Specialist - London, United Kingdom - Precision for Medicine

Precision for Medicine

Verified Company

London, United Kingdom

1 week ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Precision for Medicine is not your typical CRO.
The Senior Study Start Up (SSU) Specialist is a seasoned, experienced professional in country site start-up activities.

Responsibilities will be dependent upon the location of the SSU according to the applicable regulations and processes governing study and site start-up and activation.

Typically, these include activities such as Informed Consent Form review and adaptation, Regulatory 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 Sr.

SSU acts as Subject Matter Experts for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for non-experienced staff on site start-up activities as well 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:

Responsible for delivery, in terms of timeliness and quality, of site activation within the assigned country/sites and foreseeing and mitigating any risks.
Preparation/Support of EC/IRB submissions, collection and review of regulatory documents, notifications to IRB, EC and regulatory authorities, as appropriate.
Preparation/Support the development of startup plans and essential document checklists.
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/facilitate 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.,
Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
Act as SME for collection and maintenance of local IRB/Ethics Committee (EC), other related organizations, site contracts and budget negotiations and any other start up requirements for assigned country.
Participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
If required, support Regulatory group on research of local requirements for documentation of CA submissions, approvals, and subsequent followup documentation.
Participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.
Development of country specific Country Startup summary and process flow identifying timelines, risks, and success factors.
Development of training sessions to expand Country Startup knowledge and act as Subject Matter Expert for queries.
Mentor staff on local study startup regulations, submissions, and internal procedures.
Interacts with client, participates in proposal activities, including development and client presentations as required.
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.
5 years or more as a SSU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
Experience in Contracts & Budgeting

Other Required:

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 nonEnglish speaking countries the local language of country where position based.

Preferred:

Relevant site startup (feasibility, contract negotiations, submissions) experience for the particular country.
Experience using Study Startup tracking tools/systems
Ability to prioritize workload to meet deadlines.
Can assist junior SSU activate specialists in problem resolution.

Competencies

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
Ability to follow taskspecific 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 fastpaced environment with a sense of urgency to match the pace.
Must demonstrate excellent computer skills.
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
Occasional travel may be required.

Precision