Manager, Site Contract Management Start Up

$80,000 - $146,000/Yr

Johnson & Johnson - Juneau, AK

Full-time - Manager

Remote - Juneau, AK

Chemical Manufacturing

About the position

Johnson & Johnson is seeking a Manager, Site Contract Management Start Up to join our team in Titusville, NJ. This role is pivotal in ensuring the efficient execution of site budgets, contracts, and payments related to clinical trials. The candidate will act as a subject matter expert on Global Clinical Operations (GCO) Clinical Contract Services (CCS) study start-up activities, focusing on cross-functional requirements that impact operational timelines. The position requires a strong emphasis on customer-focused leadership and collaboration to support the GCO-CCS operational strategy and the management of various studies, projects, and programs. In this role, the Manager will serve as the primary Point of Contact (POC) within GCO CCS for Global Development partners, facilitating end-to-end study start-up activities. The candidate will provide leadership and support to both functional and cross-functional teams, ensuring that project timelines are met and that work is performed to high-quality standards. The Manager will track activities and report on study status to relevant stakeholders, while also supporting country and site-level intelligence to aid in the site selection process. The responsibilities include liaising with cross-functional stakeholders throughout the study planning process to ensure contract delivery milestones align with site activation targets. The Manager will attend and participate in Cross-Functional Trial Team (CFTT) project meetings, establish methods for initiating study start-up planning, and utilize knowledge of clinical trial operations and contracting. Regular updates on study start-up progress will be provided to the GCO CCS management team and cross-functional study teams, with a focus on escalation of issues and reporting progress to internal and external study teams. The role also involves managing integration and acquisitions applicable to CCS transition and supporting continuous improvement initiatives to enhance processes.

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.
• Manage integration and acquisitions applicable to CCS transition in a project management function.
• Support continuous improvement initiatives to further enhance processes.

Requirements

• Minimum of a Bachelor's Degree is required; MBA/Advanced degree is preferred.
• Minimum of three years of relevant experience in pharmaceutical industry/clinical research.
• Expertise in drug development, clinical trial operations, and strategic planning.
• Ability to work effectively and efficiently in a group/team environment.
• Exceptional ability to conceptualize, develop and manage timelines.
• Excellent written and oral presentation skills, proficient in speaking and written English.
• Ability to communicate effectively with all levels of management and business partners.
• Proficient in conveying complex information in a manner that is understandable to a wide audience.
• Ability to teach and mentor others in group settings, one-on-one sessions and remotely.
• Ability to prioritize and organize work independently and delegate appropriately.
• Ability to manage multiple projects and prioritize and organize tasks.
• Ability to set baseline targets, track trends and implement mitigation plans.
• Considerable ability to develop and maintain productive relationships with co-workers, team members, managers and in some instances vendors.
• Demonstrated skill in using Microsoft Suite of applications (strong PowerPoint and Excel required).
• Flexibility to work globally across time zones.
• Knowledge of GCP, company SOPs, local law and regulations.

Benefits

• Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Participation in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Eligibility for the Company's long-term incentive program.
• 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 of Work, Personal and Family Time - up to 40 hours per calendar year.