Clinical Evaluations Coordinator (Remote )

The Planet Group

Deerfield Illinois

United States

Healthcare - Physician
(No Timezone Provided)

Job Purpose:
To assist Group Heads and Clinical Evaluation Specialists contributing to the conduct of Clinical Evaluations for Life-Cycle management and the provision of technical documentation. Will collaborate with other functions in Research and Development to ensure the timely production of compliant clinical evaluations and high quality supporting documents.

Major Accountabilities:
Manage clinical evaluation projects. Ensure high quality and timely delivery of tasks/projects. Responsible for project information flow (resources, status of assigned activities, issues) to teams and to Global/Unit Head. Interact with other Group and Function Heads to ensure proper prioritization of programs and assign adequate resources according to agreed strategy and timelines. Identify issues for the preparation and delivery of the different documents; ensure resolution of issues including anticipation; negotiate and implement solutions in collaboration with other Clinical Evaluation Group and Function Heads. Ensure adherence to internal policies and processes and to regulatory requirements.

Skills: Key Performance Indicators (Indicate how performance for this role will be measured) Timeliness and quality of deliverables produced by group of associates in accordance with the KPIs specified with respect to timelines and compliance to internal and external standards Efficiency of resource usage by adequate staffing of programs Recruitment, retention and development of talent in the group. Job Dimensions (Indicate key facts and figures) Number of associates: Direct reports: 0 Indirect reports: 0 Impact on the organization: Regulatory compliance Provide technical documentation Support product approvals/launches Support post-market activities Education: Education : PhD, MD, OD, PharmD (or equivalent) +10 years related experience Languages: Fluent English is essential Experience: Extensive knowledge of optometry/ophthalmology is preferred Excellent written and oral skills The individual must have strong understanding of study design, analytical and data interpretation, and reporting skills In-depth knowledge of clinical regulatory requirements for clinical regulatory documentation, including expert knowledge of current medical device regulations Extensive experience with data interpretation and presentation of regulatory documents for clinical development programs Expertise in the preparation of documents for submission to health authorities in support of marketing applications Excellent knowledge of regulatory document requirements, creation, management and publishing processes and tools Requirements: Skills: Key Performance Indicators (Indicate how performance for this role will be measured) Timeliness and quality of deliverables produced by group of associates in accordance with the KPIs specified with respect to timelines and compliance to internal and external standards Efficiency of resource usage by adequate staffing of programs Recruitment, retention and development of talent in the group. Job Dimensions (Indicate key facts and figures) Number of associates: Direct reports: 0 Indirect reports: 0 Impact on the organization: Regulatory compliance Provide technical documentation Support product approvals/launches Support post-market activities

Education: Education : PhD, MD, OD, PharmD (or equivalent) +10 years related experience Languages: Fluent English is essential Experience: Extensive knowledge of optometry/ophthalmology is preferred Excellent written and oral skills The individual must have strong understanding of study design, analytical and data interpretation, and reporting skills In-depth knowledge of clinical regulatory requirements for clinical regulatory documentation, including expert knowledge of current medical device regulations Extensive experience with data interpretation and presentation of regulatory documents for clinical development programs Expertise in the preparation of documents for submission to health authorities in support of marketing applications Excellent knowledge of regulatory document requirements, creation, management and publishing processes and tools

Clinical Evaluations Coordinator (Remote )

The Planet Group

Deerfield Illinois

United States

Healthcare - Physician

(No Timezone Provided)

Job Purpose:
To assist Group Heads and Clinical Evaluation Specialists contributing to the conduct of Clinical Evaluations for Life-Cycle management and the provision of technical documentation. Will collaborate with other functions in Research and Development to ensure the timely production of compliant clinical evaluations and high quality supporting documents.

Major Accountabilities:
Manage clinical evaluation projects. Ensure high quality and timely delivery of tasks/projects. Responsible for project information flow (resources, status of assigned activities, issues) to teams and to Global/Unit Head. Interact with other Group and Function Heads to ensure proper prioritization of programs and assign adequate resources according to agreed strategy and timelines. Identify issues for the preparation and delivery of the different documents; ensure resolution of issues including anticipation; negotiate and implement solutions in collaboration with other Clinical Evaluation Group and Function Heads. Ensure adherence to internal policies and processes and to regulatory requirements.

Skills: Key Performance Indicators (Indicate how performance for this role will be measured) Timeliness and quality of deliverables produced by group of associates in accordance with the KPIs specified with respect to timelines and compliance to internal and external standards Efficiency of resource usage by adequate staffing of programs Recruitment, retention and development of talent in the group. Job Dimensions (Indicate key facts and figures) Number of associates: Direct reports: 0 Indirect reports: 0 Impact on the organization: Regulatory compliance Provide technical documentation Support product approvals/launches Support post-market activities Education: Education : PhD, MD, OD, PharmD (or equivalent) +10 years related experience Languages: Fluent English is essential Experience: Extensive knowledge of optometry/ophthalmology is preferred Excellent written and oral skills The individual must have strong understanding of study design, analytical and data interpretation, and reporting skills In-depth knowledge of clinical regulatory requirements for clinical regulatory documentation, including expert knowledge of current medical device regulations Extensive experience with data interpretation and presentation of regulatory documents for clinical development programs Expertise in the preparation of documents for submission to health authorities in support of marketing applications Excellent knowledge of regulatory document requirements, creation, management and publishing processes and tools Requirements: Skills: Key Performance Indicators (Indicate how performance for this role will be measured) Timeliness and quality of deliverables produced by group of associates in accordance with the KPIs specified with respect to timelines and compliance to internal and external standards Efficiency of resource usage by adequate staffing of programs Recruitment, retention and development of talent in the group. Job Dimensions (Indicate key facts and figures) Number of associates: Direct reports: 0 Indirect reports: 0 Impact on the organization: Regulatory compliance Provide technical documentation Support product approvals/launches Support post-market activities

Education: Education : PhD, MD, OD, PharmD (or equivalent) +10 years related experience Languages: Fluent English is essential Experience: Extensive knowledge of optometry/ophthalmology is preferred Excellent written and oral skills The individual must have strong understanding of study design, analytical and data interpretation, and reporting skills In-depth knowledge of clinical regulatory requirements for clinical regulatory documentation, including expert knowledge of current medical device regulations Extensive experience with data interpretation and presentation of regulatory documents for clinical development programs Expertise in the preparation of documents for submission to health authorities in support of marketing applications Excellent knowledge of regulatory document requirements, creation, management and publishing processes and tools