Manager Clinical Research, Budgets

UT Southwestern Medical Center • Dallas, TX

2d • Onsite

About The Position

UT Southwestern is seeking a highly motivated and experienced clinical research professional with deep experience in building clinical trial budgets, sponsor negotiations, navigating coverage analysis issues, and optimizing revenue recovery on clinical studies. The ideal candidate will have prior experience in preparing and negotiating complex inpatient and drug/device studies with major pharmaceutical companies and a strong track record of mentoring and training. A deep understanding of study start-up processes and costs in an academic medical center, preferably UTSW, is highly desirable. This individual will fill a newly created position in the Office of Clinical Research (OCR), aimed at strengthening budget preparation and negotiation processes, assisting in achieving faster study start-up times, training study teams in these processes, and acting as an institutional resource for clinical trial budgets. This individual will work closely with Sponsored Programs Administration at UTSW and study teams across the institution. Independent thinking, creative problem-solving, the ability to work with multiple stakeholders on tight deadlines, and strong communication skills are essential to succeed in this position.

Requirements

• Bachelor's Degree in science, social science, business, health-related (including nursing) field or Master's Degree in science, social science, business, or health-related (including nursing) field or PhD or equivalent in science, social science, business, or health-related (including nursing) field
• 6 years of related experience to include management experience with Bachelor's Degree or 4 years of related experience to include management experience with Master's Degree or 3 years of related experience to include management experience with PhD.
• Deep experience in building clinical trial budgets
• Sponsor negotiations
• Navigating coverage analysis issues
• Optimizing revenue recovery on clinical studies
• Prior experience in preparing and negotiating complex inpatient and drug/device studies with major pharmaceutical companies
• Strong track record of mentoring and training
• Deep understanding of study start-up processes and costs in an academic medical center
• Independent thinking
• Creative problem solving
• Ability to work with multiple stakeholders on tight deadlines
• Strong communication skills

Nice To Haves

• Prior experience in the UTSW clinical research mentoring program is highly desirable
• Participation in the UTSW clinical research mentoring program may count as additional experience
• Prior experience in an academic medical center, preferably UTSW
• (BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements.
• (CPRAED) CPR AED may be required based on research study protocols or affiliate location requirements.

Responsibilities

• Reviews proposed new research studies and determines projects to implement; negotiates budget and contract issues; initiates regulatory activities; oversees preparation of necessary project summaries, consent forms, etc. for IRB; oversees compliance with all regulatory requirements.
• Oversees on-going research studies and quality assurance measures, developing criteria where necessary; negotiates favorable agreements with laboratories and collaborators on campus; monitors profitability of research studies; renegotiates contracts, supplements, etc. as needed.
• Directs financial oversight and management of clinical research unit; ensures invoicing is accurate and sponsor payments are received; ensures appropriateness of expenditures from various funding sources available to clinical research unit.
• Participates in selection process of clinical research unit staff; provides training to research, financial, laboratory, and administrative staff; evaluates staff performance and implements measures necessary to maintain quality performance and results; participates in training, development, and/or disciplinary measures; assesses policies and procedures to ensure optimal operation of clinical research unit.
• Identifies potential sponsors for clinical research unit; develops and oversees marketing strategies.
• Initiates and maintains collaborative relationships between clinical research unit and basic science facilities.
• Designs, executes, and maintains effective system of internal controls which provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable.
• Ensures compliance with applicable laws, regulations, policies, and procedures.
• Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
• Performs other duties as assigned.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100%25 coverage for preventive healthcare-no copay
• Paid Time Off, available day one
• Retirement Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF) Qualified Employer

What This Job Offers

• Job Type: Full-time
• Career Level: Manager