Job Title:

Director of Clinical Operations and Data Management

Reports To:

Executive Director

Location:

San Juan, Puerto Rico or remote

Job Summary:

To direct and manage the clinical trial start-up operations for trials through PRCCI and to manage the PRCCI pipeline of clinical trial opportunities. PRCCI and its members use the same Clinical Trial Management System (CTMS) to carry out operations, the successful candidate will be responsible for the optimal use of CTMS in order to have efficient operations and on-demand data for performance and quality management. As part of a growing organization, the role will include optimizing and carrying out processes in order to bring the best of clinical operations to our Clinical Trial Units (CTUs) and sponsors. PRCCI has an established network of partners, sponsors, and CROs, 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 for feasibility assessment and business development

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

· Support business development efforts, as needed including maintaining good relationships with sponsors and CROs, introducing clinical trial opportunities to PRCCI, and following up on these opportunities to execution

-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

· Maintain internal tools and templates for clinical trial budget and contract reviews and negotiations

-Review and negotiate clinical trial agreements

· Negotiate favorable terms for PRCCI and its members in the clinical trial agreements, in collaboration with the CTUs

· Identify contractual risks and suggest mitigating edits

-Support CTUs with regulatory documentation

· Support PRCCI members/ research sites with regulatory documentation as needed, assist in empowering sites to produce complete regulatory documents on time.

-Become the PRCCI expert "super user" of PRCCI's CTMS

· Support other PRCCI employees and employees of the PRCCI members/research sites with their CTMS activities via expert advice, organizing and/or delivering training etc;

· Become the internal manager of CTMS site portals and site versions deployment and efficient operation;

· Ensure that the CTMS is used in a continuous and effective manner;

· Manage extracting and reporting CTMS data for performance and/or quality tracking and reporting purposes;

· Manage and execute clinical trial budget building and document input within the CTMS in a consistent manner

· Build and maintain research site profiles within the CTMS, working closely with members of PRCCI

-People Management

· Manage one to two team members of PRCCI team who will be allocated partly to operations and data management

· Train as needed so that these team members will be effective in using the CTMS and in undertaking start-up operations independently

Qualifications and Skills:

·       Relevant Bachelor’s or Master’s degree, preferably in a scientific or healthcare 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 and clinical trial agreement review (preferably multi-site)

Experience in using effectively CTMS, preferably Clinical Conductor

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, preferably in Spanish as well

·       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

 

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

contact@prcci.org