Job Details

ID #49591478
State New Mexico
City Santa fe / taos
Full-time
Salary USD TBD TBD
Source J&J Family of Companies
Showed 2023-03-30
Date 2023-03-31
Deadline 2023-05-30
Category Et cetera
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Site Manager, Early Development & Clinical Pharmacology (ED&CP) – Oncology

New Mexico, Santa fe / taos, 87501 Santa fe / taos USA

Vacancy expired!

Site Manager, Early Development & Clinical Pharmacology (ED&CP) – Oncology - 2306112487WDescriptionJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for a Site Manager, Early Development & Clinical Pharmacology (ED&CP) supporting the Oncology Therapeutic Area to be remote in the United States.At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com (file:///C:/Users/jamie yacco/AppData/Local/Microsoft/Windows/Temporary Internet Files/Content.Outlook/JHNHJA6O/www.janssen.com) and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.A Site Manager I in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. A Site Manager I is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols. A Site Manager I may contribute to process improvement and training.Primary responsibilities:

Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team

Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution.

Attends/participates in investigator meetings as needed.

Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies.

Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level.

Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.

Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.

In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation.

Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed.

Ensures accuracy, validity and completeness of data collected at trial sites. Ensure appropriate measures are in place for maintenance of the blind when applicable

Ensures that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.

Maintains complete, accurate and timely data and essential documents in systems utilized for trial management.

Fully documents trial related activities with respect to study monitoring. Writes visit reports and address follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.

Reviews investigator site file for completeness and ensures archiving retention requirements, including storage in a secure area at all times.

Collaborates with TM for documenting and communicating site/study progress and issues to trial central team.

Attends regularly scheduled team meetings and trainings.

Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs.

Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV).

Prepares trial sites for close out, conduct final close out visit.

May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations.

May participate in the HA and IEC/IRB submission and notification processes as required/appropriate.

Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments.

Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology.

Coordinates site level lessons learned activities.

May contribute to process improvement and training

Qualifications

A minimum of a Bachelor’s degree in Life Sciences, Nursing or related scientific field is required

A minimum of 1 year of clinical trial monitoring experience in Oncology is required

Experience in monitoring Early Development & Clinical Pharmacology (ED&CP) studies is required

Strong computer skills and ability to learn new systems is required

Willingness to travel (up to 25%) with occasional overnight stay away from home is required

Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines is preferred

Good written and oral communication skills

Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment

Ability to work on multiple trials in Oncology

The anticipated base pay range for this position in San Francisco Bay Area, CA is MIN $78,800 to MAX $126,960.The anticipated base pay range for this position in all other US locations is MIN $68,000 to MAX $110,400.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation – up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

Holiday pay, including Floating Holidays – up to 13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefitsJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityAt Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.#GIFTSPrimary Location NA-US-New Jersey-RaritanOther Locations NA-United StatesOrganization Janssen Research & Development, LLC (6084)Job Function Clinical Trial AdministrationReq ID: 2306112487W

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