Program Delivery Manager IP Administration

Summary

IQVIA is a global provider of clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries. The Program Delivery Manager IP Administration serves as a subject matter expert for investigational product preparation and administration in clinical research, leading IPPI development, training, site support, and process improvement. The role also coordinates with study teams and clinical research stakeholders to ensure safe, efficient, and compliant drug administration across clinical trials.

Responsibilities

• Services rendered will adhere to applicable Johnson & Johnson SOPs, Wis, policies, local regulatory requirements, etc
• Co-author of the IPPI and review/provide input on all specific forms related to IP administration and dosing for all types of trials with an IPPI such as: + Administration routes (IV/SC/IM/intravesical/intraperitoneal/blood and cell products, etc.) + IV access devices (central vs peripheral, Hickman, PICC, Port, PIV, midline, etc.) + Priming and flushing procedures + Filters + Hygienic standards + Medical devices (IV pumps, syringe pumps, plasma therm, etc.)
• Support IPPI related initiatives and working groups. Actively participate in IPPI and all other nursing practice and scientific discussions. Track and integrate evolving trends in nursing practice into current and future IPPIs
• Provide input in ancillary supply selection, Ancillary Supply Questionnaire and coordinate ancillary supply related questions in close collaboration with the Ancillary Support Associate (ASA)/ Site Manager (SM)
• Develop IP administration training materials
• Set up and attend mock runs on IPPI administration before first formal IP administration at the investigational site if deemed necessary
• Support SM/IDM with resolving site IPPI related issues and site training (if applicable) according to local guidelines and blinding requirements
• Assist in site assessments/pre-trial assessment activities and study feasibility, providing recommendation from local area about site/investigator selection in collaboration with the trial team and develop IP related questions for site feasibility questionnaire
• Attend site initiation visit to support SM if deemed necessary
• Responsible for internal team training of administration process for all versions of the IPPI according to internal Standard Operating Procedures (SOPs)/Work Instructions (Wls)/Instructions for Use (IFUs) and policies for internal staff
• Point of contact for the internal study team (LTM/SM/IDM) for questions and issue resolution related to the IP administration
• Conduct ongoing dialogue with customers to understand site perspectives and enhance educational efforts as it relates to study drug administration
• Present data and information in a manner appropriate to the audience, identifying groups that would benefit from presentations and information
• Perform all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities, vTMF filing, CTMS)

Skills

• A degree in general nursing is required
• 3- 4 years of recent clinical/hospital experience is required; however, other relevant experience may be considered by the hiring manager when considering the candidate's eligibility
• Experience in antibody treatment, (Oncology (hematology and solid tumor) and / or Immunology Therapeutic Area
• Clinical trial research experience
• Knowledge of the drug development process and on International Council on Harmonization (ICH)/Good Clinical Practices (GCP) is an asset
• Strong leadership, process initiative, influencing and mentoring skills
• Experience working with virtual meeting software, Microsoft suite, including word, power point and excel and clinical systems
• Innovative and creative mindset with strong attention to details
• Strong written, oral, and interpersonal communication skills
• The ability to multi-task, work on multiple trials in parallel in different disease areas
• The ability to collaborate with all levels of management across a matrix organization
• Problem solving skills with ability to make decisions. to manage difficult clinical scenarios
• Must be proficient in speaking and writing in the country language and English

Qualifications

Must Haves

• A degree in general nursing is required
• 3- 4 years of recent clinical/hospital experience is required; however, other relevant experience may be considered by the hiring manager when considering the candidate's eligibility
• Experience in antibody treatment, (Oncology (hematology and solid tumor) and / or Immunology Therapeutic Area
• Clinical trial research experience
• Knowledge of the drug development process and on International Council on Harmonization (ICH)/Good Clinical Practices (GCP) is an asset
• Strong leadership, process initiative, influencing and mentoring skills
• Experience working with virtual meeting software, Microsoft suite, including word, power point and excel and clinical systems
• Innovative and creative mindset with strong attention to details
• Strong written, oral, and interpersonal communication skills
• The ability to multi-task, work on multiple trials in parallel in different disease areas
• The ability to collaborate with all levels of management across a matrix organization
• Problem solving skills with ability to make decisions. to manage difficult clinical scenarios
• Must be proficient in speaking and writing in the country language and English

Benefits

• Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.