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United-Biosource-Corporation

Clinical Project Research Manager - EDS/RWE/NIS

Remote — United States (see country and timezone requirements)

Check who can apply and the requirements below before continuing.

Job description

As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewardingcareer journey with UBC! Growyour career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in aninclusive workplacethat fosters creativity.

If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC!

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

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.

Originally posted on Himalayas

Who can apply

Eligible countries: United States. Accepted UTC offsets: UTC-10, UTC-9, UTC-8, UTC-7, UTC-6, UTC-5, UTC+14. Review the full description for employer-specific work authorization, residency and schedule requirements.

Ready for your next step?Apply on the official website
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