Clinical Supplies Project Manager

ICON plc•Blue Bell, SD

1d•Remote

About The Position

Clinical Supplies Project Manager - Remote, US ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are looking for a Clinical Supplies Project Manager to provide scientific and technical support to projects that have significant Pharmaceutical Supply Management, and Clinical Supplies activities associated with them and to act as the lead on appropriate project teams. You will be managing global pharmaceutical supply for all phases and pharmaceutical development activities on-going at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of our clients.

Requirements

Bachelor degree required
Drug Forecasting (Off the protocol preferred) or Demand Planning experience required.
3 plus years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
Working knowledge of the Clinical Trial Supply process
Strong experience and skills in the management of clinical supply chain logistics.
Knowledge of regulations governing investigational products, including GMP and ICH/GCP guidelines
Knowledge of project management and Clinical customer relationship building

Nice To Haves

Advanced degree nice to have
Cell and Gene Therapy expertise preferred

Responsibilities

Help to develop drug supply planning strategy and overall management of supplies for clinical studies.
Generates initial and revises drug forecast at study and program level, communicating demand requirements to CMC and other stakeholders.
Coordinates the procurement activities for comparator and NIMP and/or ancillary supplies.
Interprets relevant protocol information to develop packaging/labeling design for clinical supplies.
Establishes distribution strategy and manages packaging/distribution timelines.
Supports design and set-up of IRT system.
Coordinates the origination, proofing and transition of clinical study labels.
Proactively communicates drug supply delivery timelines to appropriate stakeholders.
Coordinates the required documentation and activities for import and export of clinical supplies.
Monitors global inventory and proactively communicates with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of a trial.
Monitors and manages retest dating for assigned study supplies.
Proactively identifies potential risks, provides corrective plans, and resolves clinical supply issues and complaints.
Provides information to support financial planning for global studies and monitors drug supply study budget.
Reviews new proposal requests and determines required clinical supplies management support.
Provides responses to potential new client request for information related to clinical supplies management

Benefits

We offer very competitive salary packages.
And to keep them competitive, we regularly benchmark them against our competitors.
Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.