**Description:**
*Job Summary*
The Contract Manager will be responsible for managing all aspects of the contract review and approval process for research agreements, coordinating with the Clinical Project Manager, and providing timely status updates to key CHI Institute for Research & Innovation (CIRI) stakeholders. The types of research agreements to be managed include confidentiality agreements (CDAs), clinical trial agreements (CTAs), amendments, work orders under a master services agreement (MSA), and other research agreements. In addition to overseeing the process, the Contracts Manager will negotiate research agreements with external partners, Sponsors and physicians/physician groups with support from the Legal Services Group (LSG) and within the scope and policy of CIRI.
The Contracts Manager will work with the LSG to develop and maintain contracting templates including standard language as well as policies and procedures. The Contracts Manager also manages and provides support to CIRI business review processes and serves as the liaison to LSG as appropriate. Additionally, the Contract Manager will be responsible for ensuring informed consent documents are drafted consistently with the CHI requirements, the protocol and the CTA or MSA.
The Contracts Manager will have supervisory responsibilities for 1-4 Contract Analysts. This includes: mentoring staff, providing best practices guidance and reviewing the work product.
*Key Responsibilities*
1. Manages the development and implementation of the contract negotiation strategy and, where appropriate, conducts contract negotiations in conjunction with the LSG as needed.
2. Manages both the LSG and CIRI business review processes and the contract review and approval process.
3. Consults with the LSG to clarify CDA, ICF and CTA contractual language as well as complex contractual issues to build understanding and clarify any revisions.
4. Supervises the activity of Contract Analysts and conducts annual performance reviews of staff.
5. Provides overview/training for internal clients on the contracts management and negotiation process.
6. Develops and maintains solid working relationships and high customer service with research partners, sponsors, CIRI staff, MBO research staff and the Legal Services Group.
7. Develops, maintains, and manages CIRI contracting policies and procedures.
8. Regularly reviews and evaluates performance of the contracts process to identify areas in need of process improvement. Oversees the accuracy and timeliness of all contracting reporting.
9. Institutes quality assurance and quality control procedures to ensure the quality of work and any reporting performed meets regulatory, contract and CIRI / CHI requirements.
10. Acts upon gathered contracting performance data and provides periodic feedback to CIRI leaders to ensure transparency and department efficiency.
11. Additional duties as assigned.
**Qualifications:**
*Job Requirements/Qualifications*
A. Education / Accreditation / Licensure (required & preferred):
* Bachelors Degree in related field required
* JD preferred, otherwise, Paralegal certification by NALA, NFPA, or AAPI required
B. Experience (required and preferred):
* Min 5 - 7 years’ experience in contracts management required
* Min 3 - 4 years of supervisory experience required
* Experience with contract management processes required
* Experience in a complex multi-regional clinical research environment preferred
* Experience successfully managing multiple projects with competing priorities (required)
* Experience with development and management of Service Level Agreements and performance management processes required
* Experience reviewing and negotiating clinical research contracts, including but not limited to: CDAs, ICFs, MSAs, and CTAs required
* Track record of successfully working in a high activity/fast paced environment required
* Current knowledge of industry standards and alternatives required
* Excellent oral and written communication and negotiation skills, including the ability to facilitate meetings and effectively lead discussions required
Additional Responsibilities:
* Demonstrates a commitment to service, organization values and professionalism through appropriate conduct and demeanor at all times.
* Adheres to and exhibits our core values :
* /Reverence/: Having a profound spirit of awe and respect for all creation, shaping relationships to self, to one another and to God and acknowledging that we hold in trust all that has been given to us.
* /Integrity:/Moral wholeness, soundness, uprightness, honesty and sincerity as a basis of trustworthiness.
* /Compassion:/Feeling with others, being one with others in their sorrows and joys, rooted in the sense of solidarity as members of the human community.
* /Excellence:/Outstanding achievement, merit, virtue; continually surpassing standards to achieve/maintain quality.
* Maintains confidentiality and protects sensitive data at all times.
* Adheres to organizational and department specific safety standards and guidelines.
* Works collaboratively and supports efforts of team members.
* Demonstrates exceptional customer service and interacts effectively with physicians, patients, residents, visitors, staff and the broader health care community.
Catholic Health Initiatives and its organizations are Equal Opportunity Employers
EOE F/M/Vet/Disabled
CBCHI
#GLDRNAT
**Job:** Clinical Research
**Primary Location:** COLORADO-ENGLEWOOD-DENVER INVERNESS
**Shift:** 1
**Scheduled Hours per 2-week Pay Period:** 80
**Weekends Required:** None
**Req ID:** 2016-R0047561