Clinical Trial Lead IV job vacancy in Yoh, A Day & Zimmermann Company, (Fort Worth, TX)

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Job Details
Company Name : Yoh, A Day & Zimmermann Company
Company Location : Fort Worth, TX
Job Position : Clinical Trial Lead IV
Job Category : Jobs in Texas

Job Description :
18 month contract
Option for remote
$89.29/hr

Accountable for all aspects of assigned clinical trials for Post-market Clinical Follow-up
(PMCF) 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 PMCF 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 PMCF 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 PMCF clinical trials to CRD. Prepare slide decks and present at
Study Review Meeting for PMCF 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 client 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 Alcon 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

Ideal Background

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 PMCF
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities [1]to contact us if you are an individual with a disability and require accommodation in the application process.

Links:
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[1] https://www.yoh.com/applicants-with-disabilities
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