Senior Manager Outsourcing

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Woodcliff Lake, NJ
5-7 Years Experience
Biotech
The Role

OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Remote Senior Manager Outsourcing. The Senior Manager of Outsourcing will support the development of outsourcing requirements for Phase I-IV global clinical trials including functional services.

Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

  • Lead and support the qualification and evaluation process for new service providers. Lead with minimal supervision the process of Request for Proposal (RFP) development from service provider selection through final contract execution.
  • Manage the contracting activities including preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments.
  • Negotiate services descriptions, budgets and payment schedules using costing tools as necessary.
  • Facilitate study kickoff/familiarization meetings to clarify timelines, statement-of-work, roles and responsibilities, and budgets.
  • Support project teams in the resolution of study specific service provider performance issues. Facilitate or attend lessoned learned meetings as necessary to incorporate improvements in new projects.
  • Manage assigned service provider relationships ensuring successful start-up and efficient outcomes, as applicable.
  • Monitor outsourcing environment to keep current on providers and industry trends.
  • Collaborate effectively with all relevant functional departments (e.g. Finance, Legal etc.) to ensure appropriate review and approval of clinical vendor contracts.
  • Maintain central database for contract tracking purposes, workload management, and metrics tracking, provide regular updates as necessary.
  • Identify areas for improvement and lead implementation of new department processes and other tasks that may be required to accomplish departmental goals and objectives.
  • Act as subject matter expert or category lead for specified service areas.

EXPERIENCE

  • BA/BS in scientific or business discipline required.
  • Direct experience (5-7 years minimum) in managing clinical contracts within the pharmaceutical industry within a clinical procurement/outsourcing function to include experience in the negotiation of contracts with Phase I-IV CROs, technical service providers, consultants etc.
  • Demonstrates business/financial acumen and thorough understanding of CRO cost models and budget as well as services and costs associated with functional service providers (e.g. IVR, Central Labs, Biostatistics, and Medical Writing, Imaging, ECG, ePRO).
  • Must have excellent written and oral communication skills.
  • Team player able to form strong cross-functional relationships, demonstrating an ability to influence/persuade others.
  • Flexible and proactive
  • Excellent analytical and problem solving skills with an eye for detail.
  • Strong understanding of financial and compliance standards.
  • Able to work with minimal supervision.
  • Highly organized with strong negotiation skills
  • Must have good leadership and project management skills.
  • Thorough knowledge of GCP/ICH Guideline and Regulations
  • Clear understanding of the drug development process
  • Displays independent thinking and good judgment.
  • Proficiency in MS Office Suite

EDUCATION

  • BA/BS in scientific or business discipline required.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

The Company
HQ: Deerfield, Illinois
1,116 Employees
On-site Workplace

What We Do

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. Visit our website to learn more: www.advancedclinical.com.

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