Logo for UBC

REMS Project Manager

Role overview

Qualifications

  • Bachelor’s Degree or equivalent experience
  • Previous managerial or relevant experience required
  • Very good written verbal and non-verbal communication skills
  • Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)

Responsibilities

  • Oversee all aspects of project conduct from start-up through close-out
  • Manage project per the scope of work and within the contracted budget
  • Serve as UBC primary contact with sponsor
  • Maintain project documentation to be 'audit ready'

About the company

UBC logo

UBC

Contract Research Organizations (CRO)

Dedicated to Global Product Safety, Brand Loyalty, and Patient Access Strategies that Support the Full Product Lifecycle United BioSource LLC (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our diverse suite of services helps bridge the gap between development and delivery and builds brand loyalty through patient access and adherence. UBC is well known for our ability to generate authoritative, real-world evidence of product effectiveness, safety, and value to assist healthcare decisions and enhance patient care. Developing a drug, taking it through commercialization, and demonstrating its post-launch value and safety is a complex journey. Regulatory hurdles and payer decision-making are increasing the complexity around drug development and product choices. UBC has aligned our expertise and industry insight to help manufacturers make informed decisions early in the product journey that ultimately optimize care and improve patient outcomes. The most successful product journeys start with great maps. UBC’s industry-leading experts work in unison to effectively navigate the product lifecycle, focusing on: Clinical Development Safety Commercialization We understand what it takes to compete in a crowded product market with many stakeholders that demand the right evidence at the right time. Our Past, Present, and Our Future UBC was founded in 2003 by industry experts with a passion for innovation and a commitment to working with pharmaceutical and biotech organizations in proving the safety, efficacy, and value of pharmaceutical and medical products. We recognized the opportunity to build an organization tailored to meet the need for scientific evidence in the healthcare industry. And, we quickly developed our core strength – the generation, analysis, and communication of real-world evidence throughout the product lifecycle.

Company details

Company typeLarge
IndustryContract Research Organizations (CRO)
Company size1001 - 5000

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

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! 

 

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 
  • Very good written verbal and non-verbal communication skills 
  • Very good supervisory skills
  • Very good interpersonal skills
  • Very good presentation skills
  • Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
  • Solution driven
  • Very good 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 PTO (Paid 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

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.

#LI-JM1

#LI-REMOTE

Apply once. Then go straight to the hiring manager.

After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
Unlocked after you apply
·

Project Manager Related jobs

Other jobs at UBC

Premium

Reach out to the hiring manager directly.

Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

  • Full match report with fit score and gaps
  • Career diagnostics on how recruiters read you
  • Curated company matches and warm intros
  • 48h early access to new roles

Cancel anytime.