Clinical Trial Assistant - Warren, United States - PHARMING GROUP

Description

About Pharming

Pharming Group N

V (Nasdaq:

PHAR/Euronext Amsterdam:
PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases.

Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development.

Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.

Our Culture

Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated.

In our growing organization, it is important that employees feel connected and engaged.

Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Overview

Pharming is seeking to hire a Clinical Trial Assistant (CTA) to bring general administrative support to the Clinical Operations Department and assistance to Project Manager(s), Clinical Project Coordinator(s) and Department Manager/Director(s) on the various tasks associated with conducting clinical trials.

Our goal is for the CTA to assist the project team in the start-up, execution, and closeout of clinical trials.

Successful execution will involve strong attention to detail, strategic planning, and meticulous follow-through of all responsibilities. This is an individual contributor role.

Key Responsibilities

The Clinical Trial Assistant (CTA) will be responsible for a wide variety of matters in support of Pharming's growth as we increase the number of both pipeline and marketed products.

Core functions include:

• Set-up, organize, and maintain clinical study documentation (e.g. Trial Master File documents, clinical study site documents, email correspondence, training materials, etc.) including preparation for internal/external audits, final reconciliation and archival.
• Collaborates in the development of study documents and reports (e.g., study protocol, IB, ICF(s), CSR, periodic safety reports, etc.), including final quality check, editing, and linking of references, to ensure proper formatting and accuracy of the content.
• Contact clinical sites for specific requests (e.g., enrollment updates, collection of essential documents, meeting arrangements, etc.).
• Provides scheduled and ad-hoc reports to provide status on study progress.
• Collect, review and track documents for CA/RA and EC/IRB submissions to confirm the applications are complete before submission and track submissions and approvals for accurate filing in the TMF.
• Prepare, ship and manage inventory of study related materials and supplies or coordinate the activities with the vendors, as applicable (e.g. CRFs, diary cards, ISF binders, etc.).
• Liaise with applicable vendor and clinical trial sites to coordinate lab supply shipments, blood sample shipment from sites to the central lab, study medication shipment, etc.
• Review Investigator/Site invoices and reconcile against the case report forms (CRFs) and budget to ensure to ensure invoices are accurate and processed under the correct billing codes.
• Collaborate with the legal department to coordinate the review and finalization of site, vendor, and consultant contracts, and ensure invoices are processed correctly.
• Schedule and attend internal and external project team meetings, and generate agenda, meeting minutes, power point slides, as needed for project, and/or departmental presentations.
• Assist with the organization of international meetings (e.g. Monitor and Investigator meetings), including selecting and organizing locations at home or abroad, accommodation, transport, facilities, etc.
• This is a hybrid role; must be able to report to the Warren, NJ office 2 to 3 days per week.

Minimum Qualifications

• Bachelor's Degree from an accredited university.
• 2+ years related experience in clinical research environment.

Preferred Qualifications

• Possess a general understanding of clinical trial and drug development process.
• Knowledge of applicable regulatory guidelines (i.e. ICH and GCP) is strongly preferred.
• Experience with an eTMF system is preferred.
• Proficient in MS- Word, Excel, and PowerPoint.
• Highly organized and detail orientated with strong time management skills.

Compensation & Benefits

• Flexible hybrid work schedule to promote a health work-life balance.
• Competitive compensation package including annual target bonus.
• Long-Term Incentive Program
• 401(k) plan with company match
• Paid-Time Off Days
• 16 Company Holidays per year (typically last week of December up until New Year's Day)

Other Benefits

• Excellent Healthcare Plans including Medical, Dental and Vision.
• Flexible Spending Accounts for Medical and Dependent Care.
• Company-provided Life Insurance, Short-Term and Long-Term Disability Plans.
• Accident, Hospital Indemnity and Critical Illness Plans.
• Pet Insurance Plan.
• On Premise Fitness Center.
• Health & Wellness Program.
• Choice of Mobile Phone for Work Use or Cell Phone Stipend.
• Pharming Academy - Continuing Learning & Development Program.

Additional Information

Pharming is committed as an Equal Opportunity and Affirmative Action employer for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, genetic information, sexual orientation, marital status, race, religion, color, national origin, disability, protected Veteran status, age, or any other characteristic protected under applicable law.

An applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request via email to HR-Unsolicited resumes from agencies should not be forwarded to Pharming.

Pharming will not be responsible for any fees arising from the use of resumes through this source.

Pharming will only pay a fee to agencies if a formal agreement between Pharming and the agency has been established.

The Human Resources/Talent Acquisition department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep submissions on file for six months.