Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy
Jobs / Job page
Project Specialist image - Rise Careers
Job details

Project Specialist

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical and play a vital role in the successful management of Expanded Access Programs (EAP), Open-Label Extension Studies (OLE), and Post Approval Named Patient Programs (PA-NPP). We challenge our team to bring thought-provoking ideas to the table and to help define and drive solutions for clients and patients. Join us in our mission to improve patient outcomes and make a difference in the field of clinical research.



Role Objectives:

As a Project Specialist at WEP Clinical, you will be responsible for the operational and administrative support of the setup, implementation, and management of EAPs, PA-NPPs, and/or OLE studies. Your responsibilities will include maintaining, organizing, and reviewing electronic trial master files, clinical trial management systems, and supporting the team in exceeding client expectations.


The Ideal Candidate:
  • Team Player
  • Adaptable
  • Detail Oriented


Principal Duties and Responsibilities:
  • Assist with the development and execution of clinical research programs, including expanded access and post approval named patient programs
  • Work with the project management team to ensure projects are completed in accordance with client expectations
  • Work with the supply chain team to coordinate and dispatch shipments of investigational products according to the WEP Clinical SOP’s
  • Support the project team and finance team with filing vendor invoices for Expanded Access Programs
  • Maintain the sponsor and site contact list
  • Communicate with sites for EAP enrolment and maintenance as needed
  • Organize and maintain shared program-level documents within internal OneDrive or SharePoint
  • Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements
  • Prepare Investigational Product Review Forms (IPRFs) and submit to WEP Clinical Regulatory team
  • Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master File (eTMF)
  • Enter and maintain program, site, and patient-level data into the EAP Clinical Trial Management System (CTMS)


Qualifications:
  • Bachelor’s degree (In a health or science field preferred)
  • 1-3 years’ experience in project management or clinical research
  • Effective verbal and written communication skills
  • Computer literacy and proficiency in Microsoft Office
  • Ability to handle confidential information with complete discretion
  • Strong organizational skills and attention to detail


What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.


We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.


We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.


Our services include:

Expanded Access Programs (EAPs)

Named Patient Programs (NPPs)

Clinical Trial Supplies (Comparator & Ancillaries)

Wren Nursing (Clinical Trial Home Nursing & Clinical Education)

Hospital Supply of Unlicensed Medicines


WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.


WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.


Average salary estimate

$60000 / YEARLY (est.)
min
max
$50000K
$70000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Project Specialist, WEP Clinical

Are you ready to embark on a fulfilling career journey? Join our dynamic team as a Project Specialist at WEP Clinical, where you will play a crucial role in managing Expanded Access Programs (EAP), Open-Label Extension Studies (OLE), and Post Approval Named Patient Programs (PA-NPP). We pride ourselves on fostering a workplace where thought-provoking ideas thrive, enabling you to propose solutions that truly impact the lives of clients and patients alike. As a Project Specialist, your role will revolve around providing operational and administrative support throughout the lifecycle of clinical research programs. Day-to-day, you'll maintain and organize electronic trial master files and clinical trial management systems, always striving to exceed client expectations. If you are a team player with a keen eye for detail, this role will allow you to assist in developing and executing critical clinical research initiatives. Collaborating closely with project management and supply chain teams, you'll ensure that investigational products are dispatched accurately and on time. Effective communication is key, as you'll engage with various sites for enrollment and documentation needs. If you have a Bachelor’s degree in a health or science field paired with 1-3 years of experience in project management or clinical research, your proactive approach and strong organizational skills will shine in this role. Be part of our mission at WEP Clinical to improve patient outcomes and bring innovative solutions to the world of clinical research!

Frequently Asked Questions (FAQs) for Project Specialist Role at WEP Clinical
What are the key responsibilities of a Project Specialist at WEP Clinical?

As a Project Specialist at WEP Clinical, you will handle diverse tasks, including managing electronic trial master files, coordinating with teams for project execution, and supporting the overall administration of Expanded Access Programs, Open-Label Extension Studies, and Post Approval Named Patient Programs. Your role is pivotal in ensuring projects align with client expectations and regulatory requirements.

Join Rise to see the full answer
What qualifications are needed to be a Project Specialist at WEP Clinical?

To qualify for the Project Specialist position at WEP Clinical, candidates should possess a Bachelor's degree in a health or science-related field along with 1-3 years of experience in project management or clinical research. Skills in communication, organization, and confidentiality, as well as proficiency in Microsoft Office, are essential to thrive in this role.

Join Rise to see the full answer
How does WEP Clinical support employee growth for Project Specialists?

WEP Clinical is committed to fostering employee growth through initiatives that encourage wellness, continuous learning, and team-building events. As a Project Specialist, you will find ample opportunities for both personal and professional development as part of a supportive and inclusive team culture.

Join Rise to see the full answer
What does the work environment look like for Project Specialists at WEP Clinical?

WEP Clinical promotes a smoke-free, drug-free, and alcohol-free work environment. Our commitment to diversity, equity, and inclusion ensures a respectful workplace that values each employee's unique identity. Project Specialists can expect a collaborative environment dedicated to improving patient outcomes and impactful clinical solutions.

Join Rise to see the full answer
What type of projects will a Project Specialist at WEP Clinical be involved in?

In the Project Specialist role at WEP Clinical, you will be involved in managing Expanded Access Programs, Open-Label Extension Studies, and Post Approval Named Patient Programs. Each project aims to provide patients and physicians with early access to life-changing treatments under stringent regulatory standards.

Join Rise to see the full answer
Common Interview Questions for Project Specialist
Can you describe your experience with clinical research programs?

When answering this question, share specific experiences where you were involved in managing clinical research programs, detailing your responsibilities and how you contributed to the project’s success. Highlight your understanding of regulatory requirements and collaboration with clinical teams.

Join Rise to see the full answer
How do you prioritize tasks in a fast-paced project management environment?

Demonstrating effective time management is key when responding. Discuss any tools or techniques you use to prioritize tasks. Provide an example of how you handled competing deadlines in your previous roles, ensuring that all critical tasks were completed on time.

Join Rise to see the full answer
What methods do you use to ensure the accuracy of project documentation?

In your answer, emphasize the processes you follow to review documentation for accuracy. Describe how attention to detail and thoroughness help you maintain high-quality standards in project documentation and compliance with regulatory requirements.

Join Rise to see the full answer
How do you handle conflicts within a project team?

When addressing this question, demonstrate your conflict resolution skills and ability to facilitate open communication. Share a past experience where you successfully navigated a team conflict and the positive outcome that resulted.

Join Rise to see the full answer
What experience do you have with trial master files and clinical trial management systems?

In your response, highlight any specific systems you have worked with and the tasks you performed within these frameworks. Discuss how you ensured the organization and maintenance of these files to support project execution and compliance.

Join Rise to see the full answer
Describe a time when you exceeded client expectations.

Share a specific example that showcases your dedication to client satisfaction. Discuss the steps you took to understand the client's needs and how your proactive approach resulted in exceeding their expectations within the project scope.

Join Rise to see the full answer
How do you maintain confidentiality and handle sensitive information?

Your answer should reflect a strong understanding of confidentiality principles. Describe your approach to handling sensitive information, adhering to both legal standards and company policies, ensuring trust among stakeholders.

Join Rise to see the full answer
What role does communication play in project management?

Emphasize the importance of effective communication in project management. Mention various methods you use to communicate with team members, stakeholders, and clients to ensure everyone is on the same page and projects remain on track.

Join Rise to see the full answer
How do you adapt to changes within a project?

Explain your flexibility and adaptability when faced with changes in project scope or timelines. Provide examples of situations where you adjusted your plans or approaches and how this positively impacted the project.

Join Rise to see the full answer
What interests you most about the Project Specialist role at WEP Clinical?

When answering this, express genuine enthusiasm for the role and its responsibilities. Discuss how WEP Clinical’s mission aligns with your professional values and how you see yourself contributing to improving patient outcomes through this position.

Join Rise to see the full answer
Similar Jobs
Photo of the Rise User
WEP Clinical Remote Morrisville, North Carolina, US
Posted 5 days ago
Photo of the Rise User
IFS Remote Colombo, Sri Lanka
Posted 6 days ago
Photo of the Rise User
Unison Consulting Pte Ltd Remote No location specified
Posted 5 days ago
Photo of the Rise User
2K Vegas Hybrid Las Vegas, Nevada, United States
Posted 7 days ago
Photo of the Rise User
Posted 20 hours ago
Posted 17 hours ago
Photo of the Rise User
Wells Fargo Hybrid West Des Moines, IA
Posted 6 days ago
Photo of the Rise User
Axon Remote Scottsdale, Arizona, United States
Posted 7 days ago

WEP Clinical is a pharmaceutical services company focused on providing patients and health institutions access to much-needed drugs through Expanded Access Programs (EAP) and Named Patient Programs (NPP). WEP Clinical was founded in 2008 and is he...

12 jobs
MATCH
Calculating your matching score...
FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
December 8, 2024

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!