Clinical Research Manager I

Duties:  Direct the utilization of Contract Research Organizations (CROs), Central Labs. and Specialty Providers to assure the delivery of quality, timely and cost-effective external resources to support the company Development pipeline. Provide significant contribution to projects, working groups, initiatives to ensure Global CRO Management is prepared to successfully respond to the changing needs & requirements - legal, operational, regulatory & financial - of our internal & external customers, worldwide.
1. Lead the CRO/Central Lab/Reference Lab and Specialty provider selection process (on a study-by-study basis)
2. Deliver excellent value for company (cost savings, cost reductions) whenever possible
3. Assist Clinical Teams in definition of work specification and also in some cases actually define the work specifications including the amendment scope
4. Assure CROs/Central Labs/Specialty Providers are always delivering to a high level of quality
5. Responsible for negotiation of multi-million dollars contracts
6. Negotiate contract terms, pricing and payment schedule, ensuring that the agreements with the CROs/Central Labs/Specialty Providers are commercially advantageous to client. Develop milestone payments on the CRO side.
7. Minimize regulatory, legal, and financial risks
8. Produce final contracts/amendments and secure all necessary company approvals to ensure SOX compliance.
9. Manage ongoing CRO/Central Labs/Specialty Provider collaborations (business conflicts, issue resolution, project status, adherence to budget, periodic provider appraisals, etc.).
10. Deliver quality contracts through close collaboration with functional partners such as legal, Finance, QA, and functional lines
11. Serve as primary interface between client and CRO/Central Labs/Specialty Provider senior management.
12. Manage the interface with internal and external key stakeholders to enhance outsourced trials to be successful

Skills:
1. At least 5 years experience in Drug Development in Pharmaceutical Industry or with a CRO/Central Lab/Specialty Provider.
2. Basic understanding of the clinical development process and solid understanding of the management of clinical trials.
3. Demonstrated ability of completing projects on time and within budget.
4. Excellent influencing and negotiation skills.
5. Solid understanding of contracts (including basic legal understanding of terms and conditions).
6. Good financial understanding (understanding of cost drivers for clinical trials) as it relates to contracts and cost reductions.
7. Excellent written and oral communications skills.
8. Strong problem solving skills.
9. Demonstrated willingness to make decisions and to take responsibility for such.
10. Excellent interpersonal skills (team player).

Education: BA/BS/MBA or equivalent desirable

At least 5 years experience in Drug Development in Pharmaceutical Industry or with a CRO/Central Lab/Specialty Provider.  Good financial understanding (understanding of cost drivers for clinical trials) as it relates to contracts and cost reductions., Not Specified