Title: Interactive Response Technology (IRT) Lead Duration: 18 Months Location: Collegeville, PA Hybrid role The preferred location is Collegeville, PA, or Groton, CT but HM is also open to interviewing remote candidates. If a candidate is near a site it would be preferable for them to be on site 1-2 days per week for training.
Description: The IRT Global Oversight Team (IGOT) is a well-established high performing team within Global Clinical Supply unit striving to deliver best in class Interactive Response Technology (IRT) systems providing randomization and drug management capabilities in support of dynamic investigational product portfolio. The patients we serve are our number one priority and IGOT aims to employ the highest quality standards across our internal and vendor IRT solutions. As part of an innovative clinical supply chain, we routinely challenge the status quo in efforts to optimize our systems and processes.
ROLE SUMMARY The IRT Lead is a role within the Engagement function in IGOT that will serve as a strategic partner and single point of accountability to partner lines for protocol assessments, requirements elicitation, system deployments, and resupply settings guidance for IRT system developed with external vendors. The implementation of this role is intended to strengthen key interfaces within assigned therapeutic areas, streamline processes and increase agility.
The IRT Lead will be assigned when it is determined that an IRT system may be needed at the draft protocol stage. He or she will perform a preliminary protocol assessment with the Supply Chain Lead (SCL), Clinical Research Pharmacist (CRP) and clinical team members (e.g., clinician, biostatistician) to determine the most effective IRT strategy for clinical customer, investigator site, Global Clinical Supply, and ultimately for the patient. The IRT Lead will present the key preliminary requirements and IRT system recommendations to the IRT Protocol Assessment Group for final determination.
He or she will work to elicit additional protocol requirements from the clinical team, then partner with the IRT vendor to ensure the IRT system is programmed according to the protocol, test scripts are complete and accurate, and execute User Acceptance Testing (UAT) in order to successfully deploy the system into production.
The IRT Lead will serve as a member of the Clinical Supply Team and as the IGOT POC throughout the life of the study. For ongoing studies, he or she will also be available for guidance on IRT resupply settings and any requisite system amendments.
In addition to developing new IRT systems, the IRT Lead would be assigned ongoing studies that have come into through an acquisition. He or she will work to integrate these studies to align with standards and work within processes. This will include identifying IRT functionality and processes at the IRT vendor that need to be modified to align with processes. The IRT Lead would be responsible for working with the vendor and study team to implement this system and/or procedural changes.
The IRT Lead will also partner with IGOT management for quality investigations, CAPA commitments and continuous improvements, SOP review and revision activities, support regulatory inspections, and limited duration teams where appropriate.
For this position candidates will need to be able to think outside of the box, and have excellent communication and analytical thinking skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio.
ROLE RESPONSIBILITIES • Serve as a strategic partner and POC for protocol assessment and IRT system selection for assigned studies. • Work with the IRT vendor to elicit and document system requirements for new and amended studies in partnership with the SCL, CRP and clinical team. • Write and execute UAT test plans where UAT is employed. • Work with the IRT vendor to create IRT supportive documents and investigator meeting slides for clinical teams and investigator site personnel. • Train partnering lines on the system functionality applicable to their study. • Provide technical expertise and knowledge sharing across engagement and system design teams to ensure consistency in standards, design and strategic decision making. • Review ongoing studies coming in through acquisition to identify IRT functionality and procedural changes that need to be implemented to integrate the study into IGOT team for support. • Contribute to or lead cross line initiatives and quality investigations • Provide input into SOPs and process development and aid in quality investigations and CAPA resolution. • Serve as the IRT representative on Clinical Supply Teams for assigned studies. • Serve as subject matter expert during regulatory inspections for assigned studies. • Assist in the oversight and onboarding of new vendors and active studies coming into IGOT team through acquisition.
QUALIFICATIONS • BA/BS, in computer science, life science, or business field required in the biopharma industry. Advanced degree desired. • Minimum 9+ years of industry experience with IRT, clinical supply, and/or business analysis desired • Understanding of the nature of clinical data and concepts of IRT study configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards • Knowledge and experience working in a GMP / GCP environment and with regulatory audit teams • Project management and/or continuous improvement experience or certification such as PMP, CBAP, AIM or Lean Six Sigma Green Belt/Black Belt a plus • Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required • Comfortable working with a global team, partners and customers in a change agile environment
PHYSICAL/MENTAL REQUIREMENTS • Database query, business analysis and technical writing skills a plus • Experience participating in root cause analysis using tools such as FMEA, 5-Why, Cause & Effect Matrix and/or Fish Bone diagram • Experience with business analysis and/or project management tools a plus (ex. MS Project, MS Visio, HP Quality Center, or any other requirements visualization and analysis tools) • Comfort with facilitating requirements elicitation sessions, modeling requirements, and negotiation of business needs as they apply to system functionality. • Ability to represent IRT function in a high-pressure environment (e.g., during regulatory inspections).
Hard Skills: 1. IRT Skills (build and support systems) 2. Working with Vendors oversight
Preferred Skills: 1. People skills
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $58.95/hr.
