Clinical Outsourcing Lead

Integrated Resources Inc.; Collegeville (PA); On-site; USD 100,000 - 130,000; Full time

Job summary

A premier staffing firm is seeking a Director Level (P05) position focused on clinical budgeting and operational expertise in study scheduling. Candidates should possess a BA/BS degree and substantial experience in clinical trials. Strong communication skills and proficiency in relevant software are essential. This role demands strategic negotiation and contracting skills to manage complex clinical studies.

Qualifications

• Preferred education, experience, and attributes are essential.
• Clinical trials Sponsor experience is required.
• Significant experience negotiating clinical trial-related agreements is essential.

Responsibilities

• Demonstrates understanding of clinical & per subject costing.
• Identifies solutions for complex problems impacting business units.
• Leads efforts in operational impact assessments on timelines and budgets.

Skills

Finance / clinical budgeting

Operational expertise in study scheduling

Negotiating and contracting skills

Excellent oral/written communication skills

Education

BA or BS degree

Advanced degree (MBA, JD, etc.)

Tools

MS Office applications (Word/PPT/Excel)

ACW

ClearTrial

Grants Manager

Job description

A Few Words About UsIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Overview

Responsibilities

• Finance / clinical budgeting
• Demonstrates clear understanding of activity based costs along study path; additionally, Director Level (P05) demonstrates expertise in strategic cost relationships and links (program, asset, portfolio, etc.) for planning and forecasting, negotiation, and higher level presentation
• Understands components of clinical & per subject costing & use of industry benchmarking
• Operational expertise in study scheduling and placement
• Knowledge of clinical study outsourcing; Director Level (P05) requires expert knowledge in clinical trial development outsourcing
• Understanding of operational impact to timelines, budget, and quality desired, and required for Director Level (P05)
• Negotiating and contracting skills
• Knowledge and experience of contracting with external service providers
• Application of contracting strategies at enterprise levels
• Internal and external influencing abilities for expectation and timeline management; for Director Level (P05), proven experience required
• Identifies and leads efforts to examine multiple solutions or innovative options in solving highly complex problems directly impacting a Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit

Qualifications

• (i.e., preferred education, experience, attributes)
• BA or BS degree and/or recognized amount of work experience (preferably in a related discipline).
• An advanced degree (MBA, JD, etc.), prior management responsibilities, and/or substantial work experience is preferential for the Director Level (P05).
• Clinical trials Sponsor experience, CRO operational and/or BD experience, or other trial related experience, including significant experience negotiating and drafting clinical trial-related agreements is required.
• Excellent oral/written communication skills and proficiency with MS Office applications (Word/PPT/Excel) required: experience with ACW, ClearTrial, Grants Manager and / or other industry cost and planning tools preferred.

Additional Information

Warm Regards,

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012 & 2013 (7th Year)