Site Investigational Product Specialist

Job description

Job Title: Site Investigational Product Specialist

Location: Belgium, Netherlands, UK, France, Germany, Spain

GCF 24/25
Business: Janssen

Who is Janssen? We're more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer's disease to cancer, we are committed to issues that touch everyone's lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring cutting-edge science and the most creative minds in the industry together to think differently about diseases. We aim not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health.

We are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines: the best available treatment at an affordable price. That's why we at Janssen strive to provide access to effective and affordable medicines and related healthcare services to the people who need them.

Key Responsibilities:

Joining as a Site Investigational (IP) Product Specialist (SIPS) you will serve as a key contact point between the sponsor and the investigational site (both commercial and non-commercial) for Investigational Product Preparation Instructions (IPPI) training of studies with a complex IP administration process. Your focus will be on IPPI review and training/implementation of IP administration steps for all compounds deemed requiring training plans. Working as the Site Investigational Product Specialist you will be the key internal and external interface to ensure overall IPPI adherence and contribute to continuous process improvement, training and mentoring for IPPI. The Site Investigational Product Specialist may perform Site and/or Trial Manager tasks as described in GCO procedural documents for ED&CP studies (up to 40%).

· Play a key role in the safe, efficient and effective IP administration in clinical trials.
· Review and provide input on IPPI, Site Investigational Product Procedures Manual (SIPPM), monitoring guidelines and all specific forms related to IP administration and dosing before finalization as applicable.
· Process risk assessment review where applicable.
· Assist in site/lab assessments, pre-trial site assessment activities and/or study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team.
· Close collaboration with the Drug Product Development (DPD) team and the Drug Preparation Administration Team (DPAT) around IPPI.
· Attend primary DPAT kickoff meeting as ad hoc member as needed.
· Early connection with investigational site pharmacy and nursing staff to review site IP process and equipment.
· Close collaboration with GTL, SM, TM, Independent Drug Monitor (IDM) and Pharmacy Investigational Product Specialist (PIPS) for all IPPI related topics.
· Evaluate and support process for IP ancillary supplies/administration kits are compatible with the site equipment/practice in the country/investigational site.
· Review of site's dispensing and accountability records to ensure key information is captured to confirm dose delivery and administration is documented e.g. infusion rates/volumes.
· Review translation of IPPI and/or related documents into local language per policy and regulations.
· Provide feedback on eCRF setup regarding IP administration.
· Collaboration on IP training material development with key stakeholders.
· Attend key site initiation visits. Responsible for training of all versions of IPPI through dose escalation and administration according to internal Standard Operating Procedures (SOPs)/Work Instructions (WIs)/Instructions for Use (IFUs) and policies. Support IP issue resolution and work closely together with the IDM to ensure site training for blinded trials.
· Set up and attend mock runs on IPPI administration before first formal IP administration at the investigational site if applicable.
· Observe first dosing on site and/or support SM/IDM/PIPS if allowed according to local guidelines and blinding requirements.
· Point of contact for the internal study team in the country for questions related to the IP administration.
· Review any modification of IPPI, SIPPM manual, specific forms related to IP administration and dosing during the applicable phases of the trial.
· Fully document trial related activities with respect to IPPI site training and monitoring (e.g. writing of visit reports and completion of follow-up letters to investigators). Documentation and escalation of major deviations and issues to appropriate stakeholders. Ensure timely corrective actions are completed and documented. Coordinate documentation with SM/IDM, as appropriate.
· Lead and/or participate in special initiatives as assigned for IPPI and SIPPM development.
· Establish and maintain good and productive working relationships with internal and external stakeholders (e.g. nurses, investigators,…).

Desired profile

Qualifications :

Candidate Requirements:
·  A minimum of a Bachelor's degree in Nursing is required.
·  A minimum of 2-3 years of clinical trial research experience is required.
·  Experience in monitoring Early Development and Clinical Pharmacology studies preferred.
·  Experience in Oncology and Immunology Therapeutic Areas strongly preferred.
·  Experience with biologics preferred.
·  Experience with IV infusions and SC or IM injections strongly preferred.
·  Experience with various types of central and peripheral Lines, Mediport access, medication administration syringes and various types of infusion pumps preferred.
·  Experience in clinical practice within hospitals/academic centers strongly preferred.
·  Strong knowledge of the drug development process, including International Council on Harmonization (ICH)/Good Clinical Practices (GCP), local regulatory requirements, assigned protocols and associated protocol specific procedures, including monitoring guidelines, required.
·  Experience working with computer software applications required.
·  Experience with clinical systems preferred.
·  Must have strong leadership, process initiative, influencing and mentoring skills.
·  Must have creative and flexible mindset with strong attention for details.
·  Must have good written and oral communication skills.
·  Must be proficient in speaking and writing the country language and English. Speaking an extra language (French, Spanish, German and/or Dutch) is an asset.
·  The ability to work at a fast pace within small exploratory study teams with accelerated cycle times is required.
·  The ability to work on multiple trials in parallel in different disease areas is required.
·  The ability to collaborate with all levels of management across a matrix organization is required.
·  Willingness to travel 50% (on a local and/or international level), approximately 2-3 days each week, with overnight stays, is required.
·  A valid Driver's License.

Make a unique mark in your career

If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com

We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.