REMS Senior Project Manager

United Biosource Corporation; États-Unis; À distance; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Remote opportunities

Growth opportunities for promotion

401K with company match*

Flexible work environment

Discretionary PTO (Paid Time Off)

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Wellness program

Adoption assistance

Short term disability

Long term disability

Life insurance

Résumé du poste

United Biosource Corporation is seeking a REMS Senior Project Manager to lead project teams from initiation to close-out, coordinating sponsors, investigators, and vendors across REMS-related studies. You will drive milestones, budgets, and regulatory deliverables while building strong client relationships.

The role requires in-depth knowledge of GCP/ICH guidelines, effective supervision of PMs, and the ability to influence cross-functional teams.

Qualifications

• BA Degree or minimum 5 years of direct project management experience at a CRO or proven leadership/management experience.
• Excellent supervisory skills.
• Excellent interpersonal skills and presentation abilities; decisive risk mitigation.
• Strong knowledge of regulatory requirements (GCP, ICH, etc.).
• 10% travel requirement and willingness to travel as needed.

Responsabilités

• Serve as the primary sponsor contact for all study-related items from start-up through close-out, adhering to SOPs, budgets, timelines and contracts.
• Lead cross-functional project activities and special projects; supervise PMs and team members to ensure on-time delivery.
• Assist in the development of protocols, CRFs, regulatory documents and project master files; ensure audit readiness.
• Develop and manage communication, monitoring, and training plans; track progress against plans and ensure compliance.
• Lead investigator meetings, negotiate budgets, and support client proposals and RFP responses.
• Support project audits and regulatory inspections; provide timely reporting to sponsors; mentor junior staff.

Connaissances

Project management

Supervisory skills

Interpersonal skills

Presentation skills

Regulatory knowledge

Travel willingness

Formation

Bachelor's degree

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

REMS Senior Project Manager

UBC / SRM / REMS PM - WPK Regular Research & Clinical Remote, US

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Job Title: YLM01I – Senior Clinical Project Research Manager

Brief Description:Lead UBC project teams to deliver project milestones

Specific Job Duties

• Serve as the primary contact with the sponsor for all study related items, with oversight of all aspects of project conduct, from study start-up through close-out in accordance with company and project specific SOPs, guidelines, budgets, timelines and contracts
• Execute operational aspects of assigned project activities as well as special projects
• Assist in the development and design of protocols, CRFs, regulatory documents, project master file, and other project related deliverables
• Ensure operational plans are developed consistent with project needs, including but not limited to, the development of communication plans, monitoring plans, project plans, training plan, study timelines, Compliance Plan and clinical management plans; monitor project progress as compared to established plans and ensure compliance with plans
• Facilitate and plan investigator meetings; recruit qualified investigators and assist in budget negotiations as required
• Supervise APM/PMs and other team members to ensure project deliverables and timelines are delivered accurately and timely; provide reports to the Sponsor on project progress
• Lead projects with cross functional involvement and supervise all functional areas that support the project
• Assist in revenue and invoicing for project(s)
• Supervise all functional areas that support the project
• Ensure project training occurs and assist with training for project, as assigned
• Serve as a resource to team members for all inquiries and issue resolution for site management, contract budget and remediation, and regulatory document preparation
• Lead internal client teleconferences and/or meetings and present project information at client meetings, bid defenses and UBC monthly project review meetings
• Maintain project documentation to be “audit ready”
• Support APM/PMs in sponsor/regulatory audits as required
• Assist in preparation of client proposals in response to RFPs
• Ensure project budget is tracked against contract milestones
• May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
• Initiate and lead process improvement activities
• Accurate reporting and interpretation of project metrics
• Proposal and implementation of action plans
• Satisfactory delivery of contracted services and achievement of contracted milestones for assigned projects
• Duties described for Project Manager and other duties as assigned by management

Supervisory Responsibilities

• Supervision of project management staff in execution of assigned projects
• Prepare PMs to make presentations to clients in defense of proposals
• Ensure that the APM/PM understands the client needs once a project is awarded
• Serve as a resource and mentor to the APM/PM in the execution of their daily activities
• Proactively assist the APM/PM in anticipating and seeking resolutions to potential and actual project issues
• Motivate project team members by fostering teamwork

Desired Skills and Qualifications

• BA Degree or minimum 5 years of direct project management experience at a CRO or proven leadership/management experience
• Excellent supervisory skills
• Excellent interpersonal skills
• Excellent presentation skills
• Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
• Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
• 10% travel

Expected Project Load

2 to 3 projects depending on scope

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

• Remote opportunities
• Growth opportunities for promotion
• 401K with company match*
• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.