Site Activation Partner II

 The Site Activation Partner II (SAP II) is responsible for leading or supporting 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.

 Responsibility span within a country or multi-country depending on the geographical region and

business needs.

Reports to the ExecuPharm (EP) assigned Line Management with day-to-day direction from Client.

Refer to Organizational Chart for details regarding assigned role and associated reporting structure

 Partners with Global Site and Study Operations (GSSO), Clinical Development and Operations

(CD&O), Regulatory Affairs, Pharmaceutical Sciences, Medical Quality Assurance, Legal, and Drug

Safety Unit

Clinical Trial Site Activation & Conduct

 Initiate and coordinate activities and essential documents management towards the compilation of

a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval

 Register investigator sites in Client registries and systems as required. Update and regularly

maintain the registry with accuracy and have it inspection ready

 Work directly and interact with investigator sites to complete critical information and readiness for

site activation; inclusive of but not limited to IIP essential documents components, study contracts

contacts, clinical supply shipment information, payment information, Investigator Review Board

(IRB) submission and status

 Take the lead to resolve issues or concerns and timely escalation of issues where applicable

 Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms,

Food and Drug Administration (FDA) 1572 revisions, for internal regulatory approval within required

timelines

 Lead a subset and assist with the overall site activation process and coordinate operational

activities to ensure timely site activation

 Take the Lead and Coordinates the compilation of the Central IRB package and submissions to

approval of the study

 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 preparation, handling and distribution of Clinical Trial Supplies and maintenance of

tracking information as needed

 Initiate and coordinate activities and essential documents management with the investigator’s sites

(post site initiation visit (SIV)) during study conduct 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 revisions, Ethics Committee annual approvals

 Responsible for timely filing of documents to Trial Master File and other systems and assist with

periodic quality review of study files for accuracy and completeness QualificationsSchool diploma/certificate with equivalent combination of education, training and experience;

BS/BA or bachelor’s degree in life sciences preferred

 Minimum 6 years relevant experience in Clinical Trials environment and clinical site activation.

Experience working in the pharmaceutical industry/or CRO is an asset

 Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local

country regulations

 Must be fluent in Local language and in English.

 For individuals based in Canada: Bilingualism (French, English) is an asset

 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

 Experience working in a global environment

 Experience in working in more than 1 country is an asset

 Demonstrated knowledge and understanding of key operational elements of a clinical trial and

processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain

command of these processes

 Understand the quality expectations and emphasis on right first time. Demonstrate compliance with

all applicable company, regulatory and country requirements. Attention to detail evident in a

disciplined approach

 Proven 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.