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Mgr, Clinical Contracts

Irvine, CA 92614

Posted: 02/21/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 600522 Is job remote?: No Country: United States

Job Description

Target PR Range: 45-55/hr
*Depending on experience 

As the Clinical Contracts Manager, you will be responsible for the full clinical contract lifecycle including partnering closely with clinical study teams, hospitals, vendors, consultants, Legal, Finance and Compliance groups to develop and lead the execution of a variety of clinical contracts while applying legal and clinical expertise.

The position will be on-site at our Irvine headquarter 5 days/week.

How you will make an impact:

Draft, negotiate, and execute the full contract lifecycle for a variety of site and vendor contracts (HCP and non-HCP), including securing appropriate approvals (i.e., Compliance, Legal, Annual Needs Assessments (ANA), and RFPs) where applicable while collaborating with internal stakeholders and external customers utilizing appropriate systems (e.g., Electronic Contracts Lifecycle Management System (ECLM))
Identify and lead continuous and/or process improvement initiatives across a variety of cross-functional teams within own business unit (BU) or cross-BU teams; may also provide guidance and support to lower-level staff in initiatives they are leading; may provide input on legal-owned contract templates
Oversee ongoing vendor lifecycle management, including new supplier onboarding, supplier qualification, COUPA activation/de-activation, annual supplier review/scorecards, and post-project review; Collaborate with clinical stakeholders to identify and qualify new suppliers utilizing appropriate systems (e.g., SmartSolve)
May assess needs/impacts for contract and budget amendments and provide recommendations to key stakeholders while ensuring compliance with company policies and mitigating risks to the company; may create contract amendment or form letter templates
May train and mentor lower level staff on clinical contracting matters, company policies, and company systems; assist in developing, finalizing, and updating training and guidance documents
Assist leadership with a variety of analytics or metrics related to executed contracts and budgets or other ad-hoc requests; including establishing reports on various company systems, running ongoing reports, and providing analysis and metrics on key data
Other incidental duties

What you will need (Required):

Bachelor's Degree in related field PLUS 8 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes

Master’s Degree or Juris Doctor PLUS 6 years of previous related experience with Clinical Study Agreements, Informed Consents, Consulting and/or Vendor contracts along with knowledge of supplier qualifications processes
What else we look for (Preferred):

Experience in healthcare related (clinical, HCP) contracts

Additional skills:

Proven expertise in Microsoft Office Suite and related contract systems
Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
Excellent problem-solving and critical thinking skills
Extensive knowledge and understanding of policies, procedures, and guidelines relevant to contract negotiation and administration
Extensive understanding of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act)
Extensive understanding of regulatory requirements (e.g., CFR, GCP) and documents
Extensive knowledge of clinical research and operations acumen
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including serving as consultant to management
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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