Senior Site Manager - Oncology (1 of 2)

Senior Site Manager - Oncology (1 of 2)

19 Sep 2024
Missouri, Helena 00000 Helena USA

Senior Site Manager - Oncology (1 of 2)

Vacancy expired!

Janssen Research & Development, LLC, a member

of Johnson & Johnson's Family of Companies, is recruiting for a Senior

Site Manager - Oncology. This position

can be located remotely within the United States.At the Janssen Pharmaceutical Companies of Johnson &

Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing

some of the most devastating and complex diseases of our time. And we pursue

the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and

develops innovative medical solutions to address important unmet medical needs

in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular

and metabolic diseases. Please visit

http://www.JanssenRnD.com for more information.The Senior

Site Manager (Senior SM) will serve as the primary

contact point between the Sponsor and the Investigational Site. This individual will be assigned to trial

sites to ensure inspection readiness through compliance with the clinical trial

protocol, company Standard Operating Procedures (SOPs), Good Clinical Practices

(GCPs), and applicable regulations and guidelines from study start-up through

to site closure. Responsibilities may

include assisting with site selection, pre-trial assessment, subject

recruitment and retention planning, site initiation, on-site and remote

monitoring and close-out activities. Partner

with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical

Trial Manager (CTM) to ensure overall site management while performing trial

related activities for assigned protocols. May contribute to process improvement,

training and mentoring of other SMs.Principal

Responsibilities:

Act as primary local

company contact for assigned sites for specific trials.

May participate in

site feasibility and/or pre-trial site assessment visits.

Attend/participate in

investigator meetings as needed.

Execute activities

within site initiation and start-up, preparation and conduct of site monitoring

(including remote monitoring), site management (by study specific systems and

other reports/dashboards) and site/study close-out according to SOPs, Work Instructions

(WIs) and policies.

Implement of

analytical risk-based monitoring model at the site level and to work with site

to ensure timely resolution of issues found during monitoring visits.

Ensure site staff are

trained and the corresponding training records are complete and accurate at any

time point during all trial phases.

Work in close

collaboration with LTM and central study team for the activities during site

activation phase in order to speed up the process and activate the site in

shortest possible timeframe.

Contribute to site

level recruitment and retention strategy and contingency planning and

implementation in partnership with other functional areas.

Ensure site study

supplies (such as Non-Investigational Product (IP), lab kits, etc.) are

adequate for trial conduct.

Ensure that clinical

drug supplies are appropriately used, handled and stored and returns are

accurately inventoried and documented.

Arrange for the

appropriate destruction of clinical supplies.

Ensure site staff

complete data entry and resolve queries within expected timelines.

Ensure accuracy,

validity and completeness of data collected at trial sites

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.

Maintain complete,

accurate and timely data and essential documents in relevant systems utilized

for trial management.

Fully document trial

related activities, in particular monitoring. Writes visit reports and

follow-up letter in accordance with the SOPs. Promptly communicates relevant

status information and issues to appropriate stakeholders.

Review study files for

completeness and ensures archiving retention requirements are met, including

storage in a secure area at all times.

Collaborate with LTM

for documenting and communicating site/study progress and issues to trial

central team.

Attend regularly

scheduled team meetings and trainings.

Comply with relevant

training requirements. Act as local expert in assigned protocols. Develops

therapeutic knowledge sufficient to support role and responsibilities.

Work closely with LTM

to ensure Corrective Action Preventative Action (CAPA) is completed for Quality

Assurance (QA) site audits and for quality issues identified at the site during

routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit

(OSQMV).

Prepare trial sites

for close out, conduct final close out visit.

Track costs at site

level and ensure payments are made, if applicable.

Establish and maintain

good working relationships with internal and external stakeholders, investigators,

trial coordinators and other site staff.

May participate in the

Health Authority (HA) and Independent Ethics Committee

(IEC)/Institutional Review Board (IRB) submission and notification

processes as required/appropriate.

Act as a point of

contact in site management practices.

May be assigned as a

coach and mentor to a less experienced SM.

May contribute to

process improvement and training.

Lead and/or

participate in special initiatives as assigned.

May assume additional

responsibilities or special initiatives such as “Champion” or Subject Matter

Expert”.

Qualifications

A minimum of an Associate’s degree or completion of a Nursing Program (RN) is required. A Bachelor’s degree in a Health or Science discipline is preferred.

A minimum of 2 years of clinical trial monitoring experience is required.

Clinical research monitoring experience in Oncology is required.

Experience with CAR-T (Cell and Gene Therapy) is preferred.

Experience with Phase II and Phase III Clinical Trials is preferred.

Knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.

Strong computer skills in appropriate software applications and related clinical systems required.

Must have strong written and oral communication skills.

Willingness to travel 50%, approximately 2-3 days per week, with overnight stays (1-2 nights on average), is required.

A valid Driver's License issued in one of the 50 United States and a good driving record is required.

Johnson & 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 disability.Primary LocationUnited States-New Jersey-Raritan-Other LocationsNorth America-United StatesOrganizationJanssen Research & Development, LLC (6084)Job FunctionClinical Trial AdministrationRequisition ID0437190724

Job Details

  • ID
    JC2714864
  • State
  • City
  • Full-time
  • Salary
    N/A
  • Hiring Company
    J&J Family of Companies
  • Date
    2019-09-19
  • Deadline
    2019-11-17
  • Category

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