Site Contract Lead

Tarrytown, NY
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Type: Contract

Category: Scientific & Clinical

Job ID: 153138

Date Posted: 08/06/2020


Site Contract Lead,

S
UMMARY/POSITION OBJECTIVE: Briefly describe the general nature and purpose of the job (2-3 sentences) For assigned studies: responsible for (1) managing the CROs who develop and negotiate global investigator site contracts, (2) reviewing CROs’ and/or sites’ proposed changes to standard contract terms and the study-specific budget parameters (in partnership with other business lines internally), (3) ensuring the delivery of high quality, compliant, effective, and timely site contracts, (4) maintaining productive relationships with internal client groups, and (5) working on ongoing process improvements and guidance documents.

 

JOB DUTIES: List essential (6-10) to be performed. These are the most critical responsibilities

Essential Functions required for the job. List both technical and managerial requirements if applicable.

 

• Provide subject matter expertise for assigned therapeutic areas

• Accountable for ensuring that performance and efficiency standards are met for assigned studies

• Perform in a manger that is consistent with Company’s values

• Assist with updating Company’s site contracting processes

• Engage with the study teams from early planning throughout the end-to-end contracting lifecycle

• Work closely with internal client groups, internal stakeholders, and CROs and effectively communicate with them, in order to ensure that business objectives are met (e.g., scheduled site initiation visit deadlines)

• Handle site contracting related escalations from the CROs and/or the investigator sites, effectively and efficiently

• Develop and enhance relationships with internal clients, internal stakeholders, CROs, and sites

• Partner with colleagues in the Law Department and other stakeholder groups, as needed, to continuously enhance Company’s CTAs

• Ensure that internal systems are updated in a timely, accurate, and complete manner

• Ensure that CROs and staff are enhancing site relationships and conducting issue resolution of moderate to high complexity

• Meet with study teams regularly and prioritize assignments

• Stay abreast of changes in industry standards and help identify new best practices to contribute to continuous improvement

• Help train others on site contracting processes and industry practices

• Manage changes to study scope, ensuring timely contract amendment and implementation

• Responsible for making timely decisions and direction of outcomes

• Address changes to study scope to ensure timely contract amendment and implementation

• As a member of cross-functional study teams, lead appropriate agenda topics of the team meeting and provide guidance to line functions

• Single point of contact for internal clients, CROs, and sites for assigned studies

 

 

JOB REQUIREMENTS: List knowledge, skills, and abilities required

to perform the job.

 

List any preferred job requirements as well.

 

• Ability to mitigate and drive solutions regarding CRO and investigator site contracting challenges

• Ability to identify and implement best practices and contribute to continuous improvement for site contracting

• Ability to influence vendors and internal stakeholders

• Strong knowledge of site contracting practices

• Comfortable participating on and occasionally leading cross functional teams of peers (internal/external customers)

• Functional subject matter expert

 

Minimal educational requirements:

 

Bachelor’s Degree

Master’s Degree or Juris Doctor (Preferred)

 

Required Licenses & Certificates:

Minimum Years of Experience: Please be as specific as possible

• Required minimum of 3 years of direct experience with clinical site contracting at a biopharmaceutical company, CRO, or site

 


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