Senior Clinical Trial Supply Chain & Logistics Specialist
- Employer
- Worldwide Clinical Trials
- Location
- Belgrade, Serbia and Montenegro
- Salary
- Competitive
- Start date
- 4 Nov 2019
- Closing date
- 4 Dec 2019
View more
- Discipline
- Operations, Supply Chain Management
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
We are seeking a Senior Clinical Trial Supply Chain and Logistics Specialist to join our team!
The increasingly complex clinical trials Worldwide supports may require the importation and/or exportation of investigational products, comparator products, diagnostic devices, ePRO devices, biologic samples, and other ancillary supplies worldwide. The Senior Clinical Trial Supply Chain & Logistics Specialist will coordinate with vendors, project teams, sponsors and competent authorities to ensure that assigned projects have an initial and ongoing Supply Chain and Logistics Strategy.
RESPONSIBILITIES:
Some team members may focus on a limited number of these responsibilities depending on requirements. Tasks may include but are not limited to:
OTHER SKILLS AND ABILITIES:
REQUIREMENTS:
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Description Key Responsibilities Benefits
The increasingly complex clinical trials Worldwide supports may require the importation and/or exportation of investigational products, comparator products, diagnostic devices, ePRO devices, biologic samples, and other ancillary supplies worldwide. The Senior Clinical Trial Supply Chain & Logistics Specialist will coordinate with vendors, project teams, sponsors and competent authorities to ensure that assigned projects have an initial and ongoing Supply Chain and Logistics Strategy.
RESPONSIBILITIES:
Some team members may focus on a limited number of these responsibilities depending on requirements. Tasks may include but are not limited to:
- Drive end-to-end clinical supply chain activities to ensure successful trial supply management
- Collect and maintain intelligence on the requirements of various countries importation and exportation process including regulatory processes related to the import/export activities and any other requirements as it relates to investigational medical product (IMP) and clinical trial materials (i.e. comparator product, diagnostic devices, ePRO devices, biologic samples, ancillary supplies, etc)
- Perform regulatory submissions required for successful import/export of study drugs and clinical trial materials
- Review clinical trial protocols to understand supply management requirements and coordinate with vendors, project teams, sponsors and competent authorities to develop a Supply Chain and Logistics strategy
- Coordinate with the Project Management, Site Management, and Site Activation teams to ensure that initial trial supplies are in place to support site initiation and that ongoing uninterrupted subject enrollment and treatment occurs
- Support and coordinate the labeling (in multiple languages), packaging, inventory, distribution and reconciliation of IMP/CTM for multi-national clinical studies
- Advise teams on the optimal clinical trial supply management strategy including efficient management of limited supplies when appropriate. Support the development of IRT and participate in user acceptance testing when appropriate
- Support business development during proposals, providing advice and support on import/export and other clinical supply chain questions
- Monitor inventory levels at depots and clinical sites through the life of the trial; take preventative actions to avoid potential supply issues
- Review and update SOPs and identify the need to assist in establishing new procedures
- Participate in cross-functional project team meetings
- Suggest and support the implementation of process improvements and new service lines of business
- Provide superior customer service when responding to client queries and otherwise working with the client, ensuring high levels of customer retention
- Perform other duties as assigned
OTHER SKILLS AND ABILITIES:
- Strong Planning, strategizing, monitoring and scheduling skills
- Strong written and verbal communication skills to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
- Experienced problem solving/decision-making skills.
- Good attention to detail
- Understanding of clinical research principles and process, data collection and editing skills
- Strong knowledge of FDA regulations, ICH Guidelines as well any relevant local and regional regulations, law, decree, guidelines applicable to the importation and exportation of IMP/CTM
- Demonstrated working knowledge of international regulations governing transport and distribution of CTM materials
- Understanding of standard operating procedures
- Knowledge of Word, Excel, and Outlook
REQUIREMENTS:
- Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years of clinical research experience as a clinical research associate OR
- Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years of clinical research experience as a clinical research associate OR
- 8+ years of clinical research experience as a clinical research associate or other position directly related to clinical research with a CRO, pharmaceutical or biotechnology company including 5 years' experience with supply chain and logistics
- Travel required
- Passport required
- Able to communicate clearly in English, both written and conversational
#L1-HD1
#IND-HD1
#UNCOMMONCRO
Description Key Responsibilities Benefits
Company
Find out more about working for our company
Brief Company Description;
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Company info
- Website
- https://www.worldwide.com/
- Mini-site
- Worldwide Clinical Trials
- Telephone
- +44 115 956 7711
- Location
-
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
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