Clinical Project Research Manager - EDS/RWE/NIS

United Biosource Corporation; Oregon; Hybrid; USD 90,000 - 135,000; Full time

Benefits offered by this job

Remote opportunities

Competitive salaries

401K with company match

Tuition reimbursement

Flexible work environment

Discretionary Time Off

Paid Holidays

Employee assistance programs

Medical, Dental, and vision coverage

HSA/FSA

Telemedicine (Virtual doctor)

Job summary

United Biosource Corporation is seeking an experienced Clinical Project Research Manager to lead global trials within the CRO space. You will plan, organize, and drive project teams to deliver on time and within budget, coordinating with sponsors and stakeholders across functions.

The role requires 4+ years of senior project management experience, familiarity with RWE/NIS studies, and PMP is highly preferred. Expect remote opportunities and a dynamic work environment with growth potential.

Qualifications

• Bachelor's Degree or equivalent experience required.
• Previous managerial, or relevant experience, required.
• Excellent written verbal and non-verbal communication skills.
• Excellent supervisory, interpersonal, and presentation skills.
• Ability to independently assess issues and/or mitigate risk using critical judgment to reach a resolution.
• Knowledge of regulatory requirements (e.g. GCP, ICH guidelines).
• 10% travel as required.

Responsibilities

• Oversee all aspects of project conduct from start-up through close-out.
• Manage project per scope of work and within contracted budget.
• Coordinate and facilitate all project meetings with internal and external stakeholders.
• Serve as UBC primary contact with sponsor and track milestones.

Skills

Project management

Leadership

Communication

Risk assessment

Regulatory knowledge

Education

Bachelor's Degree or equivalent experience

Job description

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!

UBC is seeking an experienced Clinical Project Research Manager with 4+ years of senior project management experience, managing global clinical trials within the CRO industry. RWE, NIS, and observational study experience is preferred. PMP from PMI is highly preferred.

Job Title: YLM01H - Clinical Project Research Manager

Brief Description : Plan, organize, and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope.

Specific job duties

• Oversee all aspects of project conduct from start-up through close-out
• Execute operational aspects of assigned project activities as well as special projects
• Manage project per the scope of work and within the contracted budget
• Manage revenue and invoicing for project(s)
• Ensure project is conducted according to UBC SOPs and client SOPs as applicable
• Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans
• Prepare project timelines and prepare or coordinate development of deliverables
• Prepare project meeting agendas and create minutes and actions logs
• Ensure project budget is tracked against contract milestones
• Serve as UBC primary contact with sponsor
• Coordinate and facilitate all project meetings with internal and external stakeholders as necessary
• Focal point for resolving project team member questions
• Supervise all functional areas that support the project
• Lead projects with cross functional involvement and supervise all functional areas that support the project
• Ensure project training occurs and assist with training for project, as assigned
• Develop content and lead Kick off Meetings both internally and externally
• Negotiate budgets and assist with remediation of contract language
• Present project information at bid defenses, client meetings and UBC monthly project review meetings
• Maintain project documentation to be "audit ready"
• Participate in sponsor/regulatory audits as required
• Coordinate investigator meeting as required
• May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
• Help lead process improvement activities
• Establish, implement and track key metrics to report on progress of project and initiatives
• Coordinate and ensure maintenance of Trial Master File as required
• May be asked to perform CSS and CRA duties as needed
• Other duties as assigned by management

Supervisory Responsibility

Supervision of project team

Desired Skills and Qualifications

• Bachelor's Degree or equivalent experience
• Previous managerial, or relevant experience, required
• Excellent written verbal and non-verbal communication skills
• Excellent supervisory, interpersonal, and presentation skills
• Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
• Solution driven
• Knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
• 10% travel as required

Benefits

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
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match
• Tuition reimbursement
• Flexible work environment
• Discretionary Time Off
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs

Equal Opportunity Statement

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 f ...