Senior Clinical Trial Specialist

Role Overview

• Executes and leads clinical trials, ensuring compliance with timelines and study milestones.
• Oversees/drives feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company SOPs.
• May serve as the primary contact for trial sites (i.e., site management).
• Develops clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
• Ensures applicable trial registration (e.g., on www.clinicaltrials.gov) from study initiation through posting of results and supports publications as needed.
• Manages/coordinates ordering, tracking, and accountability of investigational devices and trial materials.
• Partners and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Interfaces with, collaborates with and is responsible for Clinical Research Associates (CRAs).
• Coordinates and supports the development and execution of Investigator agreements and trial payments.
• Is responsible for clinical data review to prepare data for statistical analyses and publications.
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
• Ensure site staff are trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
• Ensure that all Adverse Events (AE)/Serious Adverse Events (SAEs)/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
• For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc.), contributing to cross-functional alignment.
• May provide on-site procedural protocol compliance and data collection support to clinical trial sites.
• Independently solves problems arising during clinical study execution, and will seek guidance for more complex problems, as needed.
• Responsible for communicating business related issues or opportunities to next management level.
• Knows, understands, incorporates, and follows all applicable laws and regulations relating to J&J business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be asked to provide additional support for the trial team, as needed.

Requirements

• A minimum of a Bachelor’s degree and/or equivalent University degree is required; focused degree in Life Science, Physical Science, Nursing or Biological Science discipline is preferred.
• A minimum of 4 years of professional work experience (6 years preferred)
• Previous clinical research experience required.
• Previous medical device site monitoring or equivalent experience required.
• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
• Experience and knowledge working with computer systems (Microsoft Office – Excel, Word, Power Point and Outlook).
• Strong digital literacy in appropriate software and related company clinical systems.
• Good understanding of clinical research science and processes along with an understanding of clinical trends and global clinical trial regulations.
• Proficient in speaking and writing the country language, English.

Tech Stack

• Google Cloud Platform

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time
• up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year