Job Description

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Main Purpose:

Implements guidelines established by the WHO, BATa, BMBL etc at Marken, and coordinates the biosafety monitoring, compliance, and response activities of all facilities.

Provide administrative, technical and operational support to set up BSL-1/2 S1/2 enhanced facility.

Overseeing the day-to-day operations, conduct trainings, managing the safety of the BSL-2 enhanced facility and maintaining a bio risk management system.

Main Duties and Responsibilities

• The role is highly people oriented and entails dealing directly with clients and internal operational departments for setup and implementation of projects including but not limited to the following scope:

• Patient Centric Services (e.g.Home Healthcare (HHC) visits, Direct-to/from-Patient (DTP/DFP) shipments),
• Storage and Distribution of supplies (ancillaries as well as medicinal products, such as Investigational Medicinal Product (IMP), Non- Investigational Medicinal Product (NIMP), Active Pharmaceutical Ingredients (API), Standard of Care (SoC) Commercial Product, Product(s) for Named Patient Programs (NPPs)) to investigator sites, local and regional depots, HHC providers and clinical trial participants

• Expanded Access Programs

• The rolenecessitatestaking ownership of the projectThis involves providing the client with a primary contact point and acting as the ''project owner" to coordinate the internal operational and quality departmental roles in the project.

• The Project Manageris responsible formanaging the project budget and ensuring key study deliverables aremaintainedin accordance withstudy contracts. Project activities among others encompass the support of project strategy and feasibility discussions, thecreation of a Project Management Plan betweenMarkenand its clients, development of additional project related internal and external forms and work instructions, training ofMarkenand external project stakeholders, setup of involved system (e.g.Markeninventory, track & trace or Home Health Care system), tracking of project activities and milestones, support with Quality incidents.

• Other responsibilities include dealing with project enquiries,preparationand maintenance of study reports and KPIs, supporting change order processing and project billing activities,assistingin client audits, developingSOPsand project forecasting.

• Outside of client project support, the Project Manager is expected to be an engaged member of the Project Management team, contributing to training, business process documentation, departmental activities, and the similar which will improve the department, andMarken, over time

Qualifications:

• Sound knowledge of local and global Clinical Trials Regulations

• Good Manufacturing Practice (GMP)

• Good Distribution Practice (GDP)

• Strong project management and organizational skills.

• Proven self-management skills and ability to efficiently prioritize tasks, proactive working style

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

• Excellent communication and negotiation skills with fluent written and spoken English.

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

• Understanding of a clinical trial protocol

• Strong work ethics

• Team-oriented way of working

• Ability to adapt to changes

• Minimum of 2 years project management experience, ideally in a clinical trials environment

• Graduatione.g.in Life Sciences or Logistics or other supply chain related industry or > 2 years professional experience in clinical research/pharma related industry

Employee Type:

Permanent

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