Purpose:

Support the conduct of clinical research trials at the ACPRU in accordance with all Regulatory and

AbbVie requirements by having responsibility for business operations and records management at the

ACPRU. This includes managing the ACPRU budget, headcount, contracts, vendors and GCP clinical site

documentation activities. Provide guidance and oversight to direct reports. Ensure Institutional Review

Board (IRB) approvals are received on time for study start up. This role is the liaison for the ACPRU, the

sponsor clinical teams, the IRB and facilities management.

Responsibilities:

• Financial:

o Manage functional costs for two CPPM departments within the ACPRU and review for

potential inefficiencies. Manage and report headcount on a monthly basis.

o Manage budgets for all studies conducted at the ACPRU Report, reforecast monthly study

costs to finance and oversee that all study specific SOW’s are fully executed by study start

dates.

o Manage non-IT capital for the ACPRU. Prepare RCEs and manage in Rapid database. Oversee

J50 asset inventory.

• Manage and direct responsibilities of direct reports and contractors, including performance

reviews, merit, growth plans and any other HR related activities. Assign workload and rebalance

priorities as needed.

• Obtain bids and process contracts for outsourced services. Work with Outsourcing/Purchasing to

negotiate contract terms and with CCG for contracts with HCPs. Investigate and propose

alternative solutions to high-cost ticket items.

• Manage Right of First Refusal (RFR) process working with clinical teams and outsourcing.

• Maintain Phase 1 and 2 study list based on Project Management’s Clinical Assumptions for ACPRU

Management.

• Coordinate and schedule CTODP employees during their rotation at the ACPRU. Recap experience

at the end of rotation to enhance future CTODP experiences.

• Management of multiple ACPRU vendors. Communicate and facilitate meetings with vendors on a

consistent basis. Mitigate issues when they arise. Confirm vendors are all performing up to

standards set in their contracts.

• Facility Management: Communicate regularly with AbbVie Facilities/Maintenance Groups, EHS,

Fire Chief and J50 building owner and property manager to schedule maintenance, emergency

drills and compliance walk-throughs causing minimal disruption to ongoing operations. Serve as a

main contact for ‘24 hours Call List’ for non-medical issues at the ACPRU.

• Participate in cross functional teams, example member of the Vendor Management JOT with

Advarra IRB and will participate o Allergan Sourcing Workstream.

• Bachelor's degree (Business or Science) and 10+ years of industry experience in a substantially

similar job. Master's/MBA preferred.

• Five (5) years of clinical research experience, three (3) years of supervisory experience or

experience in mentoring and training junior staff, and one (1) year experience in contract or

budget development, negotiation, and management skills.

• Strong management, leadership, organizational, problem solving, critical thinking, and negotiation

skills

• Excellent teamwork skills with all levels of personnel within R&D

• Strong written and oral communication and interpersonal skills

• Strong budget/finance experience

• Able to multitask and effectively handle multiple assignments simultaneously

• Anticipate and adjust to rapidly changing priorities

• Take initiative and identify new approaches to resolve issues that arise

• Strong understanding of Microsoft Office Applications