Senior Clinical Trial Manager - San Diego, United States - Tr1X

Description

Position Description

The Senior Clinical Trial Manager will play a key contributor role in the implementation and execution of clinical trial(s) from study start up to close-out.

The incumbent will have responsibilities for the management and oversight of CRO's, study vendors and clinical trial sites, and will partner key internal stakeholders to ensure clinical trial deliverables are completed on-time, within budget, and in accordance with regulatory requirements, GCP guidelines and internal SOP's.

The Impact You'll Make

Serve as a Study Lead to the multifunctional team to ensure clinical study/studies activities including study start-up, enrollment, maintenance and close-out are executed per timeline and budget.

Oversee aspects of study management for accurate execution of the study to ensure high quality of data.

Generate clinical trial protocol synopsis, protocols and protocol amendments with Head of Clinical Development

Facilitate CRO/Vendor selection process for outsourced activities, including developing an RFP, managing the bidding process, analysis of proposals, budgets, and leading and documenting vendor selection decisions.

Includes review of Scope of Work, budgets and negotiating contracts through execution.

Procure and manage contracts with CROs, study vendors and investigative sites.

Develop critical study documents, may include, but not limited to informed consent form templates, various management plans and study trackers.

May delegate the development of the documents to CRO but will be ultimately responsible for the quality of the documents.

Assist with and may lead development of internal meeting agendas and meeting minutes.

Develop, distribute, review and track essential trial documents and/or oversees CRO responsibility for essential documents.

Provide Regulatory Affairs with Site Essential Regulatory Documents for submission to the FDA and other regulatory agencies .

Develop and ensure compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes.

Partner in the development of the case report form (CRF) design process including content, form layout, and edit check review.

Partner in development and participates in site initiations slides and visits.

Liaise with chemistry, manufacturing, and controls (CMC) team to forecast and monitor overall drug supply and expiration to ensure adequate availability throughout trial.

Maintain a complete and updated regulatory file for each assigned site.

Manage safety reporting to sites and regulatory agencies.

Manage or provide oversight of CROs, independent field monitors and other clinical vendors.

Ensure monitoring trip reports are reviewed and track resolution of all action items and protocol deviations.

Manage, either directly or through supervised delegation, other study-wide activities such as external vendors, sample handling, drug re-supply, investigator payments, overall data quality, and overall central records quality.

Serve as in-house contact for protocol related process questions.

Audit clinical data reports for accuracy, safety, and/or efficacy trends; as necessary prepare related presentations.

Contribute to SOP development and/or review process.

Ensure Trial Master File is maintained throughout the study.

Manage direct reports and monitor assigned activities.

Provide frequent study updates to senior management upon request.

May participate and/or lead internal clinical program meetings, Investigator calls and/or Safety Review committee calls.

Other duties that may be assigned based on skill and experience.

The Team – Yes You Belong

We are building a diverse, bold, agile, and collaborative organization where each team member works closely and communicates respectfully with each other.

Tr1X leadership has high expectations for themselves and for you (and so should you): we expect the company and all its employees to be deeply focused on bringing Tr1X's cellular therapies to patients at an accelerated pace.

You Have and You Are:
A Bachelor's or Master's degree with 5 or more years of direct study management experience

Experience in cell and/or gene therapy trials, preferably in Inflammatory Bowel Disease, GvHD or other autoimmune indications

Strong working knowledge of ICH/GCP regulations

Professionalism and integrity in all actions and in relationships with management, supervisors, team members, and/or vendors.

Is adaptable team player with a 'can do' attitude who can roll up sleeves to attain goals and get tasks completed while maintaining fun and collegial mentality.

Self-starter who is motivated, driven and hungry for knowledge and experience – willing to learn, ask questions and take initiative.

Able to plan, prioritize and risk mediate and think critically with a keen sense of urgency in a fast-paced environment.

Experience in the conduct of pre-NDA, Phase 1 Fist in Human clinical trials, to include trial set-up, monitoring, and close out

Experience with electronic systems such as eTMF, CTMS, EDC, etc

Ability to work independently once onboarded and within a team structure

Excellent interpersonal, written, verbal communication, computer, organization and administrative skills

15% or more travel may be required

You are

Legally entitled to work for any employer in the US.

We offer
In addition to a competitive compensation package with stock options, Tr1X offers comprehensive benefits for our employees and their families including:

Medical

Dental

Vision

Life & AD&D Insurance

On-site fitness facilities

Flexible Time Off

401K with generous employer match

Compensation Range:
$145,000 - $165,000

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