Clinical Outsourcing, Contract Manager

Highly skilled expert with a result-driven, proven track record in clinical outsourcing and contract/vendor management for Phase 1-4 trials/IITs within international pharma/biotech companies and CROs

Experience in outsourcing in various therapeutic areas, including oncology / radiopharmaceutical, dermatology, neurology, ophthalmology as well as biosimilars

Passionate to strengthen sponsor/vendor partnerships and achieve best business value and results to clinical projects

Former Director Cost Proposals and Contracts at mid sized CRO, former Director Outsourcing & Contract Management at German Biotech Company, including building, mentoring and line managing teams

In-depth understanding and application of regulatory requirements, including ICH E6(R3)

Act as liaison between legal and operational teams, consult and ensure that adequate legal, operational as well as commercial and regulatory aspects are covered

Companies consulted with: Various Pharma clients, Biotechs and CROs

Oversee the planning, implementation and management of all contract and outsourcing aspects in several Phase 1-3 clinical trials, including Phase 4 and IITs, on a global/regional level

Provide regular reports on status, potential issues and mitigation measures to Head Clinical Operations and other internal stakeholders

Line management, mentoring and development of assigned Contract & Outsourcing Managers

Act as point of escalation for the sponsor trial team/internal stakeholders and vendors in case of issues and challenges related to contracts and budgets

Accountable for the budget and contract negotiations with vendors and clinical trial sites, including all preceding and subsequent contracts, under consideration of the optimal time, cost and quality/regulatory needs of the individual project

Responsible for managing outsourcing as subject matter expert in trial management teams to support trial progress and the program development throughout the lifecycle of a development compound

Support for identification of outsourcing needs and new vendors as subject matter expert in trial management teams, including initiation and leading RFIs/RFPs as well as bid defense meetings and subsequent vendor selection and qualification (CRO, Laboratories, Central Imaging, IxRS, Home Care Vendors, Clinical Trial Sites)

Responsible for the performance management/oversight of existing vendors and subcontractors, as well as clinical trial sites, using the performance reporting process, where established

Responsible for ascertaining the appropriate and timely involvement of all internal and external stakeholders during all stages of negotiation and contracting with vendors and clinical trial sites

Involvement in the invoice process (receive, review and approve invoices in collaboration with Trial Team Lead or other responsible functions; set up and maintain invoice tracking documents)

Preparation and updating of regular budget forecasts, both related to clinical trial budgets as well as clinical operations consultant costs

Responsible for development and maintenance of all required templates within Outsourcing and Contract Management (i.e. for vendor selection, RFP, all types of contracts, vendor performance management)

Ensure accurate trial documentation related to contracts and budgets, and inspection readiness, participate in internal audits and HA inspections as required

Stay updated on vendor markets, and the clinical outsourcing environment, maintain benchmarks on KPIs, best practices and industry trends