Program Manager, Global Site Contracting - Study Start-Up

Johnson & Johnson; Lower Gwynedd Township (Montgomery County); Hybrid; USD 137,000 - 236,000; Full time

Job summary

An established industry player is seeking a Program Manager for Global Site Contracting to lead study start-up activities. This role involves collaboration with cross-functional teams, ensuring project timelines are met, and managing site budgets and contracts efficiently. The ideal candidate will have a strong background in clinical operations, excellent communication skills, and the ability to work in a dynamic environment. With the opportunity to work remotely and the potential for travel, this position offers a chance to make a significant impact in the field of clinical research. If you're passionate about advancing healthcare and thrive in a collaborative setting, this role is perfect for you.

Qualifications

• 5+ years of experience in clinical operations required.
• Strong knowledge of drug development and clinical trial operations.

Responsibilities

• Serve as primary Point of Contact for study start-up activities.
• Provide leadership to ensure project timelines are met.

Skills

Clinical Operations

Project Management

Communication Skills

Interpersonal Skills

Problem-Solving

Education

Bachelor's Degree

Master's Degree

Tools

Microsoft Office

Job description

Job Description - Program Manager, Global Site Contracting - Study Start-Up (2506234721W)

Program Manager, Global Site Contracting - Study Start-Up - 2506234721W

Description

Johnson & Johnson Innovative Medicine R&D is recruiting for a Program Manager, Global Site Contracting - Study Start-Up. This position can be located at any Janssen site within the United States, Canada, United Kingdom, Belgium or Netherlands. Remote work options may be considered on a case-by-case basis and if approved by the company.

The Program Manager, Global Site Contracting - Study Start-Up will function as a subject matter expert on Global Clinical Operation (GCO) Contract and Centralized Services (CCS) study start-up activities, specifically related to cross-functional requirements impacting operational timelines. This individual will be responsible for the collection, management and dissemination of information required to the development and ability to execute site budgets, contracts, and payments in an efficient and effective manner. Provide customer-focused leadership and collaboration in the execution of the GCO-CCS operational strategy and management of studies, projects, and programs.

Responsibilities

• Serve as the primary Point of Contact (POC) within GCO CCS to Global Development partners in support of the end-to-end study start-up activities.
• Provide leadership and support to functional and cross-functional teams to ensure project timelines are met, work is performed to high quality standards and in an efficient manner.
• Track activities and report on the study status to relevant stakeholders.
• Support the country and site level intelligence as part of the cross functional study team to provide insights to aid in the site selection process and strategy, based on GCO-CCS experience.
• Liaise directly with cross-functional stakeholders throughout the study planning process to ensure contract delivery milestones are aligned with site activation targets.
• Attend and participate in Cross-Functional Trial Team (CFTT) project meetings, kick off meetings and investigator meetings.
• Establish and maintain methods to initiate study start up planning.
• Use knowledge of clinical trial operations with clinical trial contracting experience preferred, medical terminology, and protocol requirements relevant to site contracting.
• Track study start up progress and provide regular updates to GCO CCS management team and cross functional study team(s), both internal and external partners.
• Escalate issues and report progress to internal and external study teams, GCO CCS leadership and functional and cross-functional teams, including plans for addressing/mitigating/risks and gaps.
• Act in a project management capacity to manage integration and acquisitions applicable to CCS transition.
• Support continuous improvement initiatives to further enhance processes.

Qualifications

• A minimum of a Bachelor’s degree is required. Advanced degree (Master’s, MBA) preferred.
• A minimum of 5 years of experience in clinical operations with a Pharmaceutical company, Contract Research Organization (CRO) or investigator site is required.
• Contract experience is preferred.
• Strong knowledge in the areas of drug development and clinical trial operations is required.
• Understanding of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is required.
• Knowledge of Good Clinical Practices (GCPs) and local laws and regulations is required.
• Project management and/or strategic planning experience is preferred.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
• Previous work experience in international and virtual environments preferred.
• Flexibility to work globally across time zones is required.
• Must have excellent communication, interpersonal and presentation skills.
• Must have the ability to prioritize and organize work independently, delegate appropriately and manage timelines.
• Must have the ability to teach and mentor others in group settings, one-on-one sessions and remotely.
• The ability to convey complex information in a manner that is understandable to a wide audience is required.
• The ability to manage multiple projects, set baseline targets, track trends and implement mitigation plans is required.
• The ability to collaborate with all levels of management and business partners in a cross-functional team environment is required.
• This position will require up to 10% travel (meetings, training, etc.).

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $168,000 to $271,400.

The anticipated base pay range for this position in all other U.S. locations is $137,000 to $235,750.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.