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Clinical Contract Manager :

Company:
Artech Information Systems
Location:
Cambridge, Massachusetts, United States
Posted:
November 12, 2018

Description:

Job Description:

Job Title: Clinical Contract Manager

Job ID: BIIBJP00009821

Location: Cambridge, MA or RTP, NC (Can work either at Cambridge or RTP)

Duration: 6 Months

Position Summary

The CCM will support the outsourcing and contracting needs of global clinical development Phase I – IV programs. With responsibility for the end to end contracting process (including but not limited to validating requirements, leading competitive multi-vendor Request for Proposals, evaluating budget’s competitiveness, negotiating, building and executing statements of work and managing change orders). The CCM executes a best in class approach to vendor outsourcing and contracting for their assigned service categories of central lab, patient recruitment and retention, patient travel, site equipment, site training/portal, home health and others.

Responsibilities

• Lead vendor evaluation and selection process through Request for Proposals (RFP)

• Lead the vendor outsourcing (analysis of bid/budget responses)

• Act as the primary contact with vendors for negotiation of the scope of work, study assumptions and budget on behalf of the study team

• Collaborate with other functions to ensure execution of a quality clinical study related contract (e.g. legal, finance, and operational functions)

• Maintain contract progress updated in appropriate tools on a timeline basis

• Work closely with Vendor Contract Lead for escalation of contract progress and negotiation issues

• Ensure study outsourcing documentation, contracts and trackers are kept in an inspection readiness state at all times

• Create purchase order (PO) request for contracts and adjust PO as needed for change orders

• With input from strategic sourcing and business stakeholders, lead/oversee sourcing & negotiate Master Service Agreements & Service Level Agreements for services below the purchasing policy threshold & not covered by a sourcing strategy/preferred vendor

Minimum Education and Experience Requirements:

• Bachelor’s Degree or equivalent experience. MBA or other related business experience is a plus (business acumen – translating operations into business benefit)

• Minimum of 3+ years’ experience in the pharmaceutical/biotechnology industry in a clinical vendor management/outsourcing role

• Fully proficient in vendor contract negotiation and execution across Phase I-IV trials

• Previous experience with vendor contracts in central lab, patient recruitment and retention, patient travel, site equipment, site training/portal and home health is ideal.

Operational & Technical Skillset:

• Project management skills, including ability to handle a large volume of complex tasks and prioritize effectively

• Strong financial negotiation skills

• Ability to successfully implement change management and lead others through change

• Broad knowledge of the clinical development process (Pharma R&D and Clinical) with a clear understanding of operational and quality (GCP) aspects

• Computer proficiency in a Windows environment (e.g., MS Project, Excel, Word, PowerPoint, Visio, and Outlook), as well as ERP systems is a plus (for systems-based planning functionality), with aptitude to learn new systems

Must Haves:

1. Minimum of 3+ years’ experience in the pharmaceutical/biotechnology industry in a clinical vendor management/outsourcing role

2. Experience with end to end contracting process (including but not limited to validating requirements, leading competitive multi-vendor Request for Proposals, evaluating budget’s competitiveness, negotiating, building and executing statements of work and managing change orders)

3. Previous experience with vendor contracts in central lab, patient recruitment and retention, patient travel, site equipment, site training/portal and home health is ideal.