Trial Activation Approval Specialist III

Thermo Fisher Scientific•Georgia - Remote, GA

4d•Onsite

About The Position

The Senior Country Approval Specialist manages the preparation, review, and coordination of Country Submissions in line with the global submission strategy. The role provides local regulatory strategy advice, develops and implements local submission strategies, and coordinates with internal departments, investigators, and local regulatory authorities to support timely submissions and site activation. The specialist serves as a key country contact for submission-related activities, keeps study status information current, oversees country study files, and ensures work follows applicable company, client, and regulatory requirements. The position may also support feasibility activities, site grant budgets and payment schedules, and the identification of out-of-scope contractual activities. It may include directing or mentoring other SIA team members. Work is performed in an office, laboratory, and/or clinical environment. The position may involve exposure to biological fluids and potentially infectious organisms, as well as electrical office equipment; personal protective equipment such as eyewear, garments, and gloves is required.

Requirements

Bachelor’s degree or equivalent and a relevant formal academic or vocational qualification.
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5 or more years.
Effective oral and written communication skills.
Excellent interpersonal skills.
Strong attention to detail and quality of documentation.
Good negotiation skills.
Good computer skills and ability to learn appropriate software.
Good English language and grammar skills.
Good judgment and decision-making skills.
Basic medical or therapeutic-area knowledge and medical terminology.
Ability to work in a team environment or independently with minimal supervision, as required.
Ability to mentor fellow SIA team members positively and effectively.
Strong teamwork and team-building skills.
Basic organizational and planning skills.
Excellent knowledge of applicable regional and national country regulatory guidelines and Ethics Committee regulations.

Responsibilities

Prepare, review, and coordinate local regulatory submissions, including submissions to Ministries of Health and Ethics Committees and other applicable special national applications, in alignment with the global submission strategy.
Provide local regulatory strategy advice to internal clients.
Develop and implement local submission strategies and provide technical expertise and coordination oversight in collaboration with relevant internal departments.
Serve as a primary contact for investigators and local regulatory authorities, collaborating with the local regulatory manager on complex issues, to ensure timely submission management.
Follow guidelines and processes for effective communications with internal teams, investigators, and country regulatory authorities.
Act as the key country-level contact for submission-related activities.
Participate as required in Submission Team, Review, and Project Team meetings.
Coordinate with internal functional departments to align site start-up activities and timelines with submission activities and the critical path for site activation.
Achieve the company’s target cycle times for site activations.
Prepare regulatory compliance review packages, as applicable.
Coordinate local submission activity within SIA in accordance with the global project submission strategy.
Develop country-specific Patient Information Sheet and Informed Consent form documents.
May assist with grant budgets and payment schedule negotiations with sites.
Identify local out-of-scope activities in contracts in a timely manner and advise relevant functions.
Support coordination of feasibility activities, as required, in accordance with agreed timelines.
Ensure trial status information relating to SIA activities is accurately maintained and current in the database.
Oversee country study files and ensure they meet PPD WPD or client SOP requirements.
Maintain knowledge of and comply with applicable PPD SOPs, client SOPs and directives, and current regulatory guidelines.
Direct or mentor SIA individuals assigned to support projects, as appropriate.
Proactively identify issues or anomalies in a study’s regulatory process and resolve or escalate them as appropriate.