(Senior) Start Up & Regulatory Specialist

Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

As our company continues we grow we are seeking a Principal Regulatory and Start Up Specialist to join our growing team.

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.

• Responsible for driving country level submissions and site activation processes by coordinating activities when multiple RSSs are assigned within the country.

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.

• Interaction with CA/EC for study purposes and handling responses to the CA/EC.

• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant.

• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.

• 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.

• Prepare, 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 Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements and other required reviews to secure on time site activation for the assigned sites in the 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.

• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within PfM to ensure the conduct of Clinical Trials according to international

and local/national applicable regulations.

• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF

• May support the clinical team performing Pre-Study Site Visits.

• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.

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

• Will support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.

• Will mentor staff on local country regulations, submissions and internal procedures, as well as on PFM SSU specific guidance and tools.

• Can assume ownership of departmental process improvements / initiatives, including finalization, roll out and periodic reviews.

• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required.

• May act up in the role of Start Up Lead to drive site start up activities to meet activation timelines on smaller or single country studies or by acting as a regional Start Up Lead on larger global studies under the direction of the global Start Up Lead.

• May interact with clients during KOMs, including slide development and client presentation,as required.

Qualifications:

Minimum Required:

• Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience.

• 5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.

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 Turkish.

• Ability to prioritize workload to meet deadlines.

• Experience in driving cross-functional activities, coordination and oversight of a team.

Preferred:

• Must have relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country. Experience in country set up would be highly beneficial.

• Must have experience using milestone tracking tools/systems.

• Must be able to assist junior SU specialists in problem resolution.

• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science 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 work independently in a fast-paced 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.

• Flexible attitude with respect to work assignments and new learning.

• Occasional travel may be required

#LI-OS1 #LI-Remote

We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

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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.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

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