1.0 Overview of the Organization

1.0 Overview of the organization

The Puerto Rico Consortium for Clinical Investigation (PRCCI) was formed as part of a strategy that aims to develop Puerto Rico as a clinical research hub. PRCCI is a non-for-profit organization, which is supported by the Puerto Rico Science, Technology & Research Trust (PRSTRT), a private non-for-profit organization. PRSTRT was created in 2004 to encourage and promote: innovation, transfer and commercialization of technology & research, and foster the creation of jobs in the technology sector.

The goal of PRCCI is to promote and enhance clinical research and development for the benefit of patients, the Puerto Rican economy and global scientific innovation. PRCCI aims to improve the impact, quality and speed of clinical research in Puerto Rico. PRCCI provides a single point of contact connecting sponsors with an experienced, cooperative network of high quality Clinical Trial Units (CTUs), providing access to a variety of patient populations, and improving speed of clinical trials through faster patient recruitment and start-up processes.

2.0 Job Description

Job Title: / Clinical Operations Manager
Reports to: / Executive Director
Location: / San Juan, Puerto Rico
Purpose: / To manage the clinical trial initiation operations for trials through PRCCI. As part of a growing organisation, the role will include building, developing and carrying out processes and trialling innovative ideas in order to bring the best of clinical operations to our Clinical Trial Units (CTUs) and sponsors. PRCCI will have a network of collaborators and an individual who can manage and leverage these relationships while promoting the consortium would be most successful.
Key Responsibilities and Duties / Liaise with sponsors and CTUs to complete feasibility assessment

Facilitate clinical trial feasibility assessments and site evaluation visits, while managing study pipelines

Manage clinical trial initiation

Manage clinical trial initiation, including CTU allocation, and facilitate IRB process when needed
Be the sponsors’ single point of contact for trial specific queries
Track the end to end process on behalf of CTUs and sponsors and monitor key milestones and trial metrics

Negotiate and manage clinical trial budgets

Using your global network, understand the drivers of clinical trial budgets and benchmark levels for different types of trials
Negotiate budgets directly with sponsors, whilst liaising with CTUs

Manage CTU network

Be the single point of contact with CTUs and continuously gather feedback on PRCCI
Support CTUs to maintain up-to-date information for CTU profiles and for CTU allocation

Manage service catalogue and pricing

Manage service catalogue and pricing for our sponsors and CTUs, in line with their feedback and with global developments
Obtain regular customer feedback and liaise with business development team to improve PRCCI services

Develop and maintain framework contracts (for sponsors and CTUs)

Develop and maintain framework contract templates
Provide support to business development team during study specific or framework contract negotiations

Qualifications & Technical Job Requirements /

Relevant Bachelor’s or Master’s degree, preferably in a scientific or health care discipline
Proficient in GCP / ICH guidelines and regulations
Experience with centralized IRB processes
Knowledge of FDA reporting requirements (physician payments; pharmacovigilance etc.)
Experience in clinical trial budget management (preferably multi-site)

Experience /

3 - 5 years managing clinical trials at intermediary or service provider level (e.g. CRO / CTUs)
3 - 5 years of managing clinical trial budgets
3 - 5 years direct exposure/management of clinical trial agreements (CTAs)
Fluent in written and oral English and Spanish
Significant experience in developing strong relationships with senior stakeholders
Strong project management skills, including milestone delivery and resource allocation
Excellent oral and written communication skills
Excellent presentation and negotiation skills
Excellent interpersonal and coaching skills
Experience of framework contracts between intermediaries and Pharmaceutical firms, preferred
Experience with industry best practice resources to manage clinical trial budgets, preferred
Demonstrated ability to lead and develop staff members
Ability to develop quality business proposals

3.0 Applying for this position

All interested candidates should submit a cover letter and resume with references included to .

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