Drug Supply Trial Manager Job

DRUG SUPPLY TRIAL MANAGER needed for a CONTRACT opportunity with Yoh's client located in EAST HANOVER, NJ AREA.

WHAT YOU'LL BE DOING:

- The DSM Trial Manager (DSM TM) coordinates global DSM trial activities including planning and study set-up.
- As business partner in the CTT (Clinical Trial Team) DSM TM defines and advises the Clinical Team on the optimal study supply strategy in terms of packaging design, technical and timely feasibility, cost efficiency and risk limitation.
- Establishes, manages and communicates clinical supply plans, timelines and packaging solution with internal and external customers and partners
- Represent DSM as an active member of the CTT, ensuring clear communication and alignment between clinical needs and supply plan
- Reviews clinical trial protocol and provides input to drug sections.
- Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage Leads packaging design optimization
- Creates reviews and updates the demand plans based on changes in strategic elements/study forecasts.
- Liaises with Clinical Supply Documentation Specialist (CSDS) to define optimal label strategy ac-cording to study design HA regulatory requirements
- Coordinates the randomization of clinical supplies
- Performs medication management and coordinate the distribution of clinical supplies for non-IRT trials
- Plans budget for associated external costs for booklet labels, IRT & medication management and distribution until assignment of other DSM roles to study.
- Is accountable for creating CPRs (Clinical Packaging Request) with good quality (FTR)
- Timely communicates and updates the clinical demand plan on study level to DSM Supply Chain Managers and ensure seamless coordination of demand and supply
- Identify, assess and flag risks on a study level to stakeholders, define and communicate accordingly mitigation plan/strategy to appropriate boards (CTT, CDPM, Portfolio Review Meeting)
- Supports internal/external inspections and audits
- Actively contribute to SOP creation, revision and update

WHAT YOU NEED TO BRING TO THE TABLE:

- Advance degree preferred
- Over 4 (four) years of experience in clinical trial drug supply management required.
- Good knowledge about the Drug Development process required.
- Knowledge of relevant regulations (eg GMP, HSE etc.) and specific standards.
- Comprehensive knowledge about project management with excellent organization and planning skills.
- Demonstrates cross-functional problem-solving and idea generation skills Advanced presentation skills Good (IT) application know how required.
- Ability to work in interdisciplinary and cross-cultural teams.
- Good leadership skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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MONJOB

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SFSF: LS