Senior Local Trial Manager

Senior Local Trial Manager

05 Sep 2024
Hawaii, Hawaii 00000 Hawaii USA

Senior Local Trial Manager

Vacancy expired!

Janssen

Research & Development, LLC, a member of Johnson & Johnson's Family of

Companies, is recruiting for a Senior Local Trial Manager supporting the Cardiovascular,

Pulmonary Arterial Hypertension, Metabolism, Infectious Disease and Vaccines Therapeutic

Areas. 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 Local Trial Manager (Senior LTM) will be responsible for local

management of a clinical trial (or Medical Affairs data generation activity) in

a country or countries. This individual

will be the primary point of contact at a country level for assigned studies

and has operational oversight of assigned protocol(s) from start-up through to

database lock and closeout activities as described in Global Clinical

Operations (GCO) procedural documents. Coordinate

and lead the local trial team to deliver quality data and trial documents/records

that are compliant with the assigned clinical trial protocol, company Standard

Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory

requirements. This role may include some

site management responsibilities and may also perform the role of Clinical

Trial Manager (CTM)/Global Trial Leader (GTL) for single country as described

in GCO procedural documents.Principal

Responsibilities:

Collaborate

with Functional Manager (FM)/Clinical Research Manager (CRM) and Feasibility Process Leader or Global Feasibility Leader

(GFL) for country protocol feasibility (if applicable) and site feasibility

assessment in conjunction with the Clinical Trial Assistant (CTA) (if

applicable), Site Manager (SM) and CTM/GTL. Implement any local criteria for site

selection. Ensure consistent conduct of

pre-trial assessment visits and instruct teams on appropriate follow-up of

pre-trial visit report and country feasibility report. Recommend suitable sites for selection to

participate in trial.

Collaborate

with Global Program Leader (GPL), CTM/GTL, local management/Country Head and

other study team member to select final site list.

Contribute

input to the study management documents at a country level or initiates

development of these documents for a single country trial, as per SOPs

Lead

and coordinate local trial team activities in compliance with SOPs, other

procedural documents and applicable regulations. Lead local project planning activities to meet

recruitment targets and to deliver high quality data on time and within study

budget. Including, but not limited to: development of local trial specific

procedures and tools, recruitment planning, contingency and risk management,

and budget forecasting.

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.

Maintain

and update trial management systems. Use

study tools and management reports available to analyze trial progress.

Monitor

country progress and initiate Corrective and Preventive Action (CAPA) when the

trial deviates from plans and communicates study progress and issues to study

management teams.

May

submit requests for vendor services and may support vendor selection.

In

certain situations, may assist in negotiation of trial site contracts and

budgets. Forecast and manage

country/local trial budget to ensure accurate finance reporting and trial

delivered within budget. Adhere to

finance reporting deliverables and timelines.

Attend/participate

in Investigator Meetings as needed. May

schedule and conduct a local/country investigator meeting.

Conduct

local trial team meetings and provide or facilitate SM training when needed

(i.e. implementation of study amendment-and changes in study related

processes).

Review

and approve Monitoring Visit Reports submitted by SM and identify issues and/or

trends across a trial project and escalates deviation issues to the CTM/GTL and

Functional Manager (FM), as needed

Review

and approve site and local vendor invoices as required. Manage local study supply, as required.

Prepare

country specific informed consent in accordance with procedural

document/templates. Review and manage

site specific informed consent forms in accordance with SOPs, other procedural

documents and applicable regulations.

Organize

and ensure Independent Ethics Committee (IEC)/Health

Authority (HA) approvals, if applicable, and ensure that the trial is in

compliance with local regulatory requirements.

Work

with SM to ensure CAPA is implemented for audits and inspection or any quality

related visits.

Comply

with relevant training requirements.

Act

as subject matter expert for assigned protocols. Develop strong therapeutic knowledge to

support roles and responsibilities. May represent

GCO on cross functional teams.

Act

as primary local/country contact for a trial. Establish and maintain excellent working

relationships with external stakeholders, in particular investigators, study

trial coordinators and other site staff; and internal stakeholders, including

Medical Affairs and Marketing for Medical Affairs trials.

Actively

contribute to process improvement, training and mentoring of CTAs, SMs and

other LTMs.

Conduct

accompanied site visits with SM as delegated by FM.

May

assume additional responsibilities or special initiatives such as “Champion” or

“Subject Matter Expert”.

May

represent functional area in process initiatives as required.

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 pharmaceutical industry and/or clinical trial experience

is required.

Clinical

operations experience is preferred.

Experience

with the following Therapeutic Areas preferred: Cardiovascular, Pulmonary

Arterial Hypertension, Metabolism, Infectious Disease and Vaccines.

Knowledge

of the drug development process, including Good Clinical Practices (GCPs) and

FDA Code of Federal Regulations, is required.

Project

management experience is preferred.

Experience

mentoring/coaching and providing training to others is preferred.

Strong

computer skills in appropriate software applications and related clinical

systems required.

Must

have strong written and oral communication skills.

Must

have solid leadership skills.

Must

have a flexible mindset with the ability to work in a fast-changing

environment.

The

ability to work on multiple trials in parallel is preferred.

The

ability to lead initiative/small teams is preferred.

Minimal

business travel (meetings, training, etc.) 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 ID2920190821

Related jobs

Job Details

  • ID
    JC2681918
  • State
  • City
  • Full-time
  • Salary
    N/A
  • Hiring Company
    J&J Family of Companies
  • Date
    2019-09-06
  • Deadline
    2019-11-04
  • Category

Jocancy Online Job Portal by jobSearchi.