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Need- Specialist 3 - Clinical Trial Admin ;; Direct Client.

Infobahn SoftWorld Inc
Skillman, NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Title: - Specialist 3 - Clinical Trial Admin/Oper -

Location: SKILLMAN / NJ / 08558

Duration: 12months (with possible extensions)

Job Description:

Services Overview:
In this role, the Study Manager delivers services that include leading the operational aspects of the company's interventional and non-interventional human use clinical research studies for consumer goods and products in accordance with all applicable federal, state, and local laws/regulations and in accordance with the Company's policies, procedures, and guidelines. Conducts human use testing in areas including Essential Health, Skin Health, and Self-Care. The Study Manager will collaborate with the Study Director, Clinical Study Team, Health Care Compliance, Procurement, Bioresearch Quality and Compliance, R&D Franchise, etc., on study design and execution. These services will be primarily focused on human use clinical research programs in the Skin Health (beauty, sun, adult skincare) and Essential Health (baby skincare, oral care, & wound care) therapeutic areas.

Services rendered will adhere to applicable standard operating procedures SOPs, Work Instructions (Wis), policies, local regulatory requirements, ICH-GCP, etc.

Under minimal supervision, the Study Manager in this role:
Collaborates on the operational design and conduct of low-complexity clinical studies from protocol feasibility through study report generation and signoff, often collaborating with clinical strategy partners on methodology to best substantiate the claim and/or test the product concept.
Acquires clinical knowledge of the therapeutic area(s) and products under development.
Acquires working knowledge of regional/global regulations and guidelines as pertains to clinical research.
Has primary responsibility for protocol development in collaboration with the Clinical Study Team and based on a protocol synopsis created by the Study Director, including protocol creation, coordination of protocol reviews and approvals, finalization, and amendments as needed.
Actively assists in or manages requests for proposals (RFPs) and participates in the evaluation and selection of qualified external service providers (ESPs) (e.g., study sites, investigators).
Manages preparation of confidentiality agreements, healthcare compliance submissions, clinical trial agreements, and purchase orders, in cooperation with Healthcare Compliance and Contracting teams.
Serves as the primary point of contact with selected ESPs and as the operational lead on the study.
Prepares or reviews/approves study-specific documents including informed consent forms (ICFs), training materials, case report forms (CRFs), CRF completion guidelines, data management plans, statistical analysis plans, source documents, and recruiting materials. As needed, coordinates the translation of study-specific documents and the procurement of appropriate license agreements.
Oversees preparation, clinical release, and oversight of investigational and auxiliary products, including determining required quantities, approving clinical label copies, overseeing development of reference safety materials, and ensuring accountability and final disposition of the products.
Conducts pre-qualification assessment, site initiation, interim monitoring, and close-out visits (or oversees assigned monitor).
Trains site personnel to study-specific protocol procedures.
Ensures Sponsor oversight by monitoring the progress of studies and the performance of ESPs on a continual basis through review of monitoring plans, review of monitoring visit reports, ongoing communication with the ESPs, and maintenance of study progress via paper and electronic data capture including timely databasing of CRFs, and routing/resolution of queries.
Oversees and track subject recruitment and retention.
Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Pregnancies are reported within required reporting timelines and documented appropriately.
Ensures that all clinical studies are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety and data quality, as well as adherence to study timelines and budgets.
Sets-up and maintains Trial Master File (TMF) in real time following internal process. Coordinates the collection of all the essential documents required to authorize initial product shipment.
Generates and secures approval of study-specific documents required for registry/posting of clinical studies on public registries (e.g.,, as needed. Updates study information on public registries in accordance with registry/SOP timelines.
Tracks invoices against key deliverables; approves invoices from vendors to ensure timely payment and compliance with contracts and study budgets.
Apprises Management of study-related issues that arise. Participates in the generation of corrective and preventative action plans to address issues.
Works collaboratively and cross-functionally (both internal and external to JJFCC) with Biostatistics, Data Management, Healthcare Compliance, Research & Development, Clinical Supplies, Regulatory Affairs, Safety, Bioresearch Quality & Compliance, Procurement, Principal Investigators and their staff, and other partners.
Contributes to the writing and oversight of Clinical Study Reports, ensuring they are written and approved within required timelines.
Assists more senior Study Managers with above or additional tasks as needed for higher complexity studies.

Education and Experience Requirements/Qualifications:
Minimum of a Bachelor of Science degree in Nursing, Pharmacy, scientific field, or equivalent required
Minimum 3 years of direct industry experience including at least 1 year of project/study management experience. (Alternatively, minimum 4 years of relevant non-industry experience).
Must have excellent oral and written communication skills in English and be able to work effectively in cross-functional teams both internally and externally to the organization
Demonstrated working knowledge of the principles of drug and device development
Proficiency in ICH GCP and FDA regulations/guidelines
Strong attention to detail
Efficient, organized, and capable of prioritizing multiple tasks
Proficient in Microsoft applications including Outlook, Word, Excel, Teams, and PowerPoint
Knowledge of the TMF reference model is preferred.
Willingness to adapt to changing priorities and assignments

Infobahn SoftWorld Inc


Skillman, NJ



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