Site Activation Partner III - FSP

The Site Activation Partner III (SAP III) is responsible for leading operational activities from start up to close out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards.  SAP III is accountable for working with local business lines to lead the operational submissions to Central and/or Local Ethics as well as submissions to other governing bodies in the country (ies) within scope.  Responsibility span within a country or multi-country depending on the geographical region and business needs.

Key Accountabilities:

Main Duties-Central and/or Local Ethics interactions

• Drive Ethics Committee (EC) submission management activities for respective studies and sites

• Partners with local country stakeholders (Site operations, Regulatory) and/or preferred CROs (pCROs), with responsibility and management of required activities, and deliverables associated with Central and Local Ethics submissions

• Partners with hub stakeholders (e.g. CTA hub; contract specialists) for deliverable associated with Central and/or Local EC submissions

• Contribute to providing timelines and deliverables, to meet study and country timelines for site activation as it relates to ethics submission deliverables

• Provide status updates on submissions, queries and feedback

• Liaise with local and regional stakeholders, study teams, and pCROs for essential documents required for the submissions

• Responsible for high quality and compliant submissions

• Prepare the EC package and other associated documents according to the local requirements in collaboration with team members

• Review and cross check submission packages to ensure they meet the EC requirements

• Submits EC packages (Central and/or Local) and other bodies where applicable according to agreed timelines

• Coordinate the timely communication, documentation and responses between client and Central/Local Ethics committee to bring clinical study to approval (country dependent)

• Manage activities with Investigators sites and required documents, and perform site level ethics submissions and progress to approval

• Manage governing bodies submissions, as applicable, in countries where required (e.g. Australia)

• Manage and ensure continuation of Institutional Review Board(IRB) / Ethic’s and other committees activities post site initiation visits, and related submission, notifications, reapprovals, etc.

• Ensure timely filing of documents to electronic Trial Master File (eTMF)

• Actively participate in continuous quality improvement activities and applies quality improvement principles to all duties performed

Clinical Trial Site Activation

• Initiate and coordinate activities and essential documents management towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for sites initiation

• Provide support to resolve issues or concerns and timely escalation of site issues where applicable

• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines

• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities

• Support and implement activities in Shared Investigator Platform to align with client strategy as it relates to the role

Clinical Trials Conduct

• Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high quality documents and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, ethics committee annual approvals and other activities required during study conduct

• Ensure maintenance of IRB/Ethics and other committees’ activities as applicable

• Responsible for timely filing of documents to Trial Master File (TMF) and assisting with periodic quality review of study files for accuracy and completeness

• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines

• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Communication

• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests

• Provide functional updates on a country and site level as required

• Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals

• Disseminate central or local ethics approval to study team and Investigator sites where applicable

• Communicate local sites approvals to study team members and stakeholders

Subject Matter Expert (SME)

• A deep understanding of the site activation requirements and processes within the country/region and be able to develop and implement in more than one country to enable multi-country coverage

• May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multiple countries

  • Represent the SAP role on the study

  • Take the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globally

  • Communicate with SAPs globally on study information and timelines

• Act as SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processes

• Represent the SAP role on reginal and global initiatives

• Able to act as an SME on projects and initiatives, as requested

• Mentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a study

• Able to manage a high volume of complex studies at sites

Skills:

• Knowledge of clinical research and development processes, key operational elements of a clinical trial, and ability to gain command of process details

• Understand the quality expectations and emphasis on right first time

• Compliance with all applicable company, regulatory and country requirements

• Attention to detail evident in a disciplined approach

• Ability to work independently and also as a team member

• Ability to organize tasks, time and priorities, ability to multi-task

• Understand basic medical terminology, GCP requirements and proficient in computer operations

• Ability to use and learn systems, and to use independently

  • Microsoft Suite

  • Clinical Trial Management Systems (CTMS)

  • Electronic Trial Master File

  • Electronic Investigator Site File (e.g. Florence)

  • Document exchange portals

  • Shared Investigator Platform

  • Ethics, National Networks and Governing Bodies Portals and platforms

• Flexible and adapt to off working hours in a global environment (when applicable)

• Able to travel as needed, including some international travel possible

Knowledge and Experience:

• Background in site monitoring strongly preferred – experience with/understanding of pre-trial assessment (PTA) visits and site initiation visits (SIV)

• Significant experience with study startup/initiation within industry, including assembly of investigator initiation packages (IIP)

• Well-versed in Saudi ethics and regulatory environment; Confident in working directly with Saudi Ethics/Regulatory Committees

• Flexible to travel to sites to support assembly of Ethics submissions, PTAs and/or SIVs, or to deliver submissions to Ethics Committee (<20% travel anticipated)

• Familiarity with site budgeting/contracting processes

• Fluency in Arabic and English required

• Experience working in the pharmaceutical industry/or CRO in a similar role

• Experience of interacting with regulatory agency or Ethics Committee required

• Deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations and requirements

• Good technical skills and ability to learn and use multiple systems

• Experience working in a global environment, working in more than one country preferred

• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives

Education:

• High School Diploma/GED (or Country equivalent) with at least 10 years relevant experience in Clinical Trials, Regulatory, and ethics environment; Bachelors degree preferred

• Bachelor of Science, Bachelor of Arts, Masters of Science or equivalent with minimum of 6 years combination of education, training, experience is preferred

• Education in sciences or healthcare discipline is preferred