At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Position Summary:

• Primarily contribute to Dept. business and portfolio centralized supports and process optimization on the investigational products’ label approval, IP supplies, depot management, COA requests handling, etc., with the support of cross functions Q& C, CSC, Procurement, C& G, Legal, HCC and Finance, etc., in line with company’s requirements and business needs. Maintains key partnerships (e.g. CSC, JRP/Purchasing, Legal, Finance).
• May contribute to training and mentoring of other CTA.
• Support the Local Trial Manager and Site Manager to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials.
• Ensures central business supports and trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements.

Principal Responsibilities:

• Act as key contact person to review and approve country specific label text. Verify translation against Master English label and approved country lexicon database, and to ensure label text complies with local requirements.
• Maintain country lexicon, label requirements and distribution databases, if applicable.
• Partner with LTM, CSC, and other cross functions, such as Finance, TC, CLS, etc., to ensure all required supportive documents for drug import license application to be available and obtain drug import license, and to ensure the drug to be imported and shipped to the local medication depot successfully.
• To handle the COA requests, upon the requirements from the sites and maintain the corresponding files, complies with company’s requirements and SOP.
• Act as key contact person to address and resolve the (potential) issues identified, including but not limited on label approval, IP importation, local medication depot management, COA providing, etc., and to provide the strong inputs on the corresponding process optimization with the supports of Functional manager and cross functions, such as CSC, Q& C, Finance, Legal and Procurement, etc., in line with regulation and company’s requirement, as well as business needs.
• May act as SME member, proactively contribute to the process improvement including responsible functional areas, but not limited, in process initiatives and contribute to optimization of daily processes.
• May act as ARIBA Super user to submit the request of PO setup, and follow up the PO related issues resolution with the stakeholders Finance, HCC etc.
• May act as Trial Supply Coordinator to coordinate the management of trial supplies, proactively provide the inputs on the supply process optimization, issues address and resolution, with the support of Functional Manager, Procurement, Legal and other stakeholders.
• Act as Liaise with Finance teams, Legal, HCC, Procurement, C& G, GCO Q& C, and other stakeholders to obtain guidance and escalate issues as appropriate.
• Comply with requests from QA and auditors.
• Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
• Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.
• Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
• Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post-trial in both vTMF (i.e., IF/LAF sections) and paper files.
• Distributes, collect, review, and track regulatory documents, agreements and training documentation.
• May be assigned as a coach and mentor to a less experienced CTA.
• Complies with relevant training requirements.

Additional Responsibilities:

• Negotiates site requested changes to the Confidential Disclosure Agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations and alerts. Alerts LTM of any Prepares Trial Center File and prepare or co-ordinate the development of any other document and review them for completeness and accuracy.
• May be assigned to assist in document review for outsourced trials.
• Supports the LTM in drug management.
• Provides administrative support to the LTM/SM in tracking progress of drug importation, CoA distribution, budget, mailing and correspondence and other relevant tasks as appropriate.

Principal Relationships:

• Primary Reporting Structure: Reports to Functional Manager.
• Primary Interfaces: Functional Manager, Local Trial Manager and Site Manager(s) for assigned clinical studies.
• Other Internal Interfaces: LTM, SM, Quality & Compliance Manager/Specialist, Contracts and Grants, Clinical Trial Assistant team, CSC.
• External Interfaces: Investigators and their delegates at site.

Education and Experience Requirements:

• A minimum of a BA/BS degree is preferred.
• Skills set corresponding with preferentially 4+ years’ relevant clinical trial experience or equivalent.
• Proficient in English language.
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
• Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
• Perform activities in a timely and accurate manner.