Project Manager - Clinical Trials / Home Health Care

Marken, a UPS Company - Aston, PA3.0

Full-timeEstimated: $87,000 - $120,000 a year
Skills

About Marken

At Marken, we challenge every employee to take the initiative and achieve outstanding results. We recognize that talent is our most important asset and we offer the training, education and growth opportunities to take your career to the next level.

Marken is a wholly owned subsidiary of UPS. Marken is the only patient-centric supply chain organization 100% dedicated to the pharmaceutical and life sciences industries. Marken maintains the leading position for Direct to Patient services and biological sample shipments and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 48 locations worldwide for clinical trial material storage and distribution. Marken’s more than 900 staff members manage 55,000 drug and biological shipments every month at all temperature ranges in more than 150 countries. Additional services such as biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.

Our global presence, combined with a small company culture, provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to contribute to the company’s success.

Job Description:

The main purpose of the Project Manager’s role is the overall responsibility for the successful planning, execution, monitoring, control and closure of a clinical supply project.

Main Duties and Responsibilities:

1.The Project Manager is responsible for managing the overall set-up of the trial by creating work instructions, building protocols in our inventory management system, creating internal checklist, training functional departments on study requirements, assisting in feasibility, overseeing project budgets and ensuring key study deliverables are maintained in accordance with study contracts. The projects encompass all aspects of storage and distribution of supplies for multi-site studies or in the case of Direct-To-Patient trials encompasses all related activities in delivering to or picking up from a patient directly.

2.The role is highly people oriented and entails dealing directly with clients and internal operational groups regarding the storage and distribution of clinical trials supplies.
3. This position will manage our Clinical Trial Distribution protocols as well as our Direct-To-Patient Programs.
4. The role necessitates taking ownership for clinical supply projects. This involves providing the client with a primary contact point and acting as the ''project owner" to co-ordinate the internal operational and quality departmental roles in the project.
5. Other responsibilities include dealing with project inquiries, preparation and maintenance of study reports and KPIs, assisting in client audits, developing SOPs and project forecasting.

Requirements:

1. Comprehensive knowledge of local and global Clinical Trials Regulations to include a minimum of two (2) years project management experience in a clinical trials environment.

2. Extended knowledge about clinical trial supply, global project management, inventory systems and IVRS, GMP processes for manufacturing of clinical supplies especially labeling, packaging and randomization.

3. Strong project management and organisational skills.

4. Ability to communicate effectively with clients and manage multiple projects.

5. Excellent communication skills with fluent written and spoken English.

6. Ability to manage multiple projects proactively across a multi-disciplinary team.

General:

1. To adhere to all company Policies at all times.
2. To undertake any other reasonable duties at the request of the Line Manager.
3. Ensure compliance with national and international standards and legislation
4. Travel as reasonably requested by the Line Manager for the performance of duties.

VETERAN & EEO Employer

Job Type: Full-time

Work authorization:

  • United States (Preferred)

Required travel:

  • 25% (Preferred)