Key Accountabilities:

Clinical Trial Site Activation

Initiate and coordinate activities and essential documents management during start up towards the compilation of a high quality Investigator Initiation Package (IIP) leading to approval for site 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, Institutional Review Board (IRB) approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timeline

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

Support the compilation of the Central Investigator Review Board package and submissions to approval of the study (where applicable) and other committees as per country requirements

Coordinate the timely communication, documentation and responses between client and central ethics committee to bring clinical study to approval (country dependent)

Support investigators sites with local IRB workflow from preparation, submission through approval

Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures

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

Clinical Trial Site Support

As needed, perform, awareness session with site personnel on client requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and client standards

Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues

Subject Matter Expert (SME)

A good understanding of the site activation requirements and processes within the country/region and be able to learn and potentially implement in more than one country

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

May be assigned as an SME on a system and/or process, and represent the SAP function as applicable

May represent the SAP role on global initiatives

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

Support the mentoring of new hires on processes/ systems

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

o Microsoft Suite
o Clinical Trial Management Systems (CTMS)
o Electronic Trial Master File
o Electronic Investigator Site File (e.g. Florence)
o Document exchange portals
o Shared Investigator Platform
o Ethics, National Networks and Governing Bodies Portals and platforms (as needed)

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:

Experience working in the pharmaceutical industry/or CRO in study site activation preferred

Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations

Must be fluent in local language and in English. Multilanguage capability is preferred

Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Good technical skills and ability to learn and use multiple systems

Education:

School diploma or certificate with equivalent combination of education, training and experience or

Bachelor of Science or Bachelor of Arts or equivalent

Education in life sciences discipline is preferred

Minimum 2 years relevant experience in clinical site management