Senior Local Trial Manager (2 Openings) at Johnson & Johnson

Toronto, Ontario, Canada

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Minimum Bachelor of Science, Registered Nursing, Pharmacy or equivalent degree in Biological Sciences
Minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience
In-depth knowledge of ICH-GCP and Canadian regulations
Strong project management skills with focus on study deliverables, trial/site oversight, quality and timelines
Experience with risk-based trial management is valuable
Knowledge of several therapeutic areas. Experience in oncology is an asset
Proven skills in leadership (leading small teams)

Responsibilities

Primary point of contact at a country level for assigned studies with operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities
Coordinate and lead the local trial team to deliver quality data and trial documents/records compliant with the assigned clinical trial protocol, company SOPs, GCP, and regulatory requirements
Accountable for meeting study milestones
Support local feasibility and investigator selection
Lead study start-up activities, subject recruitment and retention planning at the country level
Handle Canadian study payments, spend and forecast management
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
Review and approve Monitoring Visit Reports submitted by Site Managers (SMs); identify issues and/or trends across a trial project and escalate accordingly
Ensure Trial Master File (essential trial documents) is complete and up to date to support audit and inspection readiness
Actively contribute to process improvement, training and mentoring of CTAs, SMs and other LTMs

Skills

Key technologies and capabilities for this role

Clinical Trial ManagementProject ManagementR&D OperationsPhase 1-4 TrialsGlobal Clinical Operations

Questions & Answers

Common questions about this position

Is this position remote or hybrid?

This is a hybrid position for candidates located in the Greater Toronto Area (GTA) in Ontario, Canada. Candidates outside of GTA may be considered on a case-by-case basis, and remote work options may be considered on a case-by-case basis if approved by the Company.

What are the main responsibilities of the Senior Local Trial Manager?

The role involves serving as the primary point of contact at the country level for assigned studies, providing operational oversight from start-up through closeout, leading the local trial team to deliver quality data compliant with protocols, SOPs, GCP, and regulations, and managing study milestones, feasibility, investigator selection, start-up activities, recruitment, payments, and informed consents.

What is the salary or compensation for this role?

This information is not specified in the job description.

What is the company culture like at Johnson & Johnson?

Johnson & Johnson emphasizes healthcare innovation to prevent, treat, and cure complex diseases, with a patient-inspired approach in Innovative Medicine where teams develop life-saving medicines and champion patients from lab to life.

What makes a strong candidate for this Senior Local Trial Manager position?

Ideal candidates are located in the Greater Toronto Area (GTA) in Ontario, Canada, with expertise in clinical trial project management across assessment/selection, initiation, maintenance, and closure phases of Phase 1-4 trials, and experience leading trial teams in a GCP-compliant environment.

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

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