Site Activation Partner II (FSP)

08 Jun 2021
08 Jul 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

ExecuPharm a PAREXEL company are currently recruiting for a Site Activation Partner II to be dedicated to one of our clients in Germany. This is a permanent office and home-based position.

Role Overview

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.

Primary Duties:
  • 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.
  • Qualifications

    Skills and Education
  • School 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.
  • 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.
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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