Clinical Trial Lead

Job Title: Clinical Trial Lead (CTL)/ Clinical Trial Manager
Department: Clinical Research & Development (CRD)
Duration: 24 Months Contract

Client Updates:

• Worker can be remote but will need to be onsite for training (4 days) and come to Fort Worth quarterly
• Bachelor’s degree is a must have qualification
• It is highly requested that this person have previous experience managing a clinical trial
• CRO experience (managed or work at) a must have qualification

Job Purpose:
Accountable for all aspects of assigned clinical trials for Post-market Clinical Follow-up
(PClientF) required by European Union Medical Device Regulation (EU MDR).
Oversee a Clinical Research Organization (CRO) running the Clinical Trial Team. The CRO
is responsible for planning, conducting and reporting on assigned PClientF clinical trials.
Oversee the development of protocols, ensuring scientific rigor and quality.
Oversee the clinical trials to ensure they are conducted with efficiency, quality, on
budget and on time.
Elevate significant issues to *** CRD Leadership.

Major Accountabilities
Oversee the CRO that is running a group of clinical trials for PClientF required by European
Union Medical Device Regulation (EU MDR).
Acts as the Liaison between the CRO and *** CRD for a book of work.
Report status of all PClientF clinical trials to *** CRD. Prepare slide decks and present at
Study Review Meeting for PClientF Clinical Trials.
Elevate significant issues to *** CRD Leadership. Lead resolution of elevated issues.
Define clinical outsourcing specifications and scope of work for clinical trial vendors.
Oversee CROs conduct of tasks and development of key deliverables such as protocol,
database, protocol monitoring plan, statistical analysis plan, informed consent template,
deviation and evaluability plan, site and patient recruitment plan, data review plan and
communication plan.
Execute Statement of Work between CRO and *** for each clinical trial.
Accountable for accuracy of trial information in trial tracking systems.
Ensure Health Authority and IRB/IEC submission and approval.
Independently ensure quality and timely execution of a clinical trial within timeline and
budget.
Manage CRO clinical trial budget and monthly accruals.
Ensure data is reported to *** in a timely manner, in an agreed upon format.
Ensure reporting of results to *** CRD and Core Team.
Oversee authoring, review and approval of the Clinical Study Report.
Ensure archiving of trial master file and other relevant documents at end of study.
Responsible for implementation of best practices and standards for trial management
with CROs, including sharing lessons learned

Qualifications:
Bachelor's degree in life science; Medical, pharmaceutical, biology, chemistry degree
preferred.
5 years in clinical research or relevant scientific, industry, therapeutic or geographic
experience
Relevant industry experience includes experience in planning and execution of clinical
studies in various phases and geographies
Experience managing or working at a CRO
Knowledge of EU MDR Requirements for PClientF