Clinical Research Pharmacist - US Remote

As a Pharmacist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

The Pharmacy Investigational Product Specialism (PIPS) services will serve as a subject matter expert for drug preparation as it relates to the process and procedure of the IPPI (Investigational Product Preparation and Administration Instructions), in clinical research. The PIPS will play a lead role in the development of safe, efficient, and effective investigational product (IP) preparation in clinical trials. The PIPS will be the key internal and external interface to ensure overall IP preparation adherence. The PIPS will be co-author of the IPPI, and will be responsible for training slide development, training level assessment evaluation, and staff training. The PIPS will give input in ancillary supply selection and ancillary supply related questions, study feasibility, site assessment and mentoring for IPPI. He/she will contribute to continuous IPPI process improvement.

The PIPS will mainly focus on PIPS tasks for trials with an IPPI.

• PIPS will be part of the IPPI author team: PIPS will be responsible for the preparation sections of the different IPPIs (IV, Subcutaneous, IM, Oral, etc.) based on the provided information about the IP (presentation, dosage, stability, material compatibility, etc.), and their expertise to identify the risk factors related to IP preparation.
• PIPS will create the IP preparation training materials for the different IPPIs and evaluate the training level required for site staff.
• PIPS will train the team on the preparation of IP for all versions of the IPPI according to the J&J SOPs and WIs.
• PIPS will be accountable for the oversight of the site trainings on the IPPI based on the Training Level

Assessment Form (TLAF).

• PIPS will remotely support the study teams with:

▪   Site trainings on IPPI, when required.

▪   Questions about IP preparation.

▪      Site findings related to the IPPI (according to SOPs, study guidelines and blinding requirements)

• PIPS will be involved in the oversight of findings related to the IPPI, including attendance of Protocol

Deviation and Issue Escalation (PDIE) meetings when required.

• PIPS will provide input in the ancillary supply (AS) process (development of AS Questionnaire, selection of supplies, etc.). PIPS will also coordinate questions related to AS in close collaboration with the Ancillary Support Associate (ASA).
• PIPS will provide input in pre-trial activities and study feasibility, including the development of IPPI- related questions for the Site Interest and Protocol Information Questionnaire (sipIQ).
• PIPS will share their hospital pharmacy background/knowledge and expertise with the Drug Product

Assessment Team (DPAT).

• PIPS will  support  IPPI  related  initiatives  and  working  groups.  They  will  actively  participate  in discussions about pharmacy practice.
• PIPS will build strong relationships with the different customers to understand the evolving pharmacy standard practices, and the current and future country and local regulations. They will integrate these trends into the current and future IPPIs.
• PIPS will perform all administrative requirements in a timely, accurate and compliant manner (e.g., time reporting, expense reports, documentation, filing of relevant communications, etc.). 

Interfaces – Primary/Other:

• Primary interfaces: Provider Functional Manager, Global Trial Leader, Country Trial Manager, Local Trial Manager, Site Manager, Pharmacy Investigational Product Specialist, Site Investigational Product Specialist, Ancillary Support Associate, Independent Drug Monitor Manager, Independent Drug Monitor, DPDS-team, Clinical Supply Integrator, CMC Leader, Study Responsible Physician, Study Responsible Scientist, Global Clinical Research Associate, CTL&D Specialist

• Other Interfaces: Quality and Compliance Manager/Specialist, R&D/Local Operating Company staff (including Medical Affairs), Bioresearch Quality and Compliance (BRQC), Investigators and their delegates at site (trial site personnel).

You are:

• Pharm D. degree with minimal 3-4 years of recent experience in a hospital or ambulatory clinic or a BS degree in Pharmacy with at least 4 years of recent experience in a hospital or ambulatory clinic is required.
• Experience in antibody treatment (Oncology (hematology and solid tumor) and / or Immunology

Therapeutic Area)

• Experience in preparing different drugs depending on the way of administration, especially intravenous, subcutaneous, and intramuscular.
• Experience in the (virtual) clinical trial setting.
• Experience in working with Microsoft Suite, including: Word, Power Point, One Note, Teams and Excel.
• Strong written and oral communication, authoring and presentation skills.
• Must be proficient in speaking and writing in the country language and English.
• Organized mindset to be able to work on multiple studies in parallel for different TA.
• Proactive, innovative, and creative mindset with strong attention to details.
• Ability to work in a team environment and to collaborate with all levels of management across a matrix organization.
• Problem solving skills with ability to make decisions.
• Speaking up when required and working under pressure

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.