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Clinical Research Contracts Manager - IRVINE, CA

Posted Mar 24
Contract
Irvine, California

Description:

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

Skills:

Clinical trial, Clinical research, contract management, clinical trial contracts

Top Skills Details:

Clinical trial,Clinical research,contract management,clinical trial contracts

Additional Skills & Qualifications:

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 Edwards 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.

Experience Level:

Intermediate Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.