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About the Role

As a Clinical Operations Delivery Associate II, you'll support audit readiness by ensuring files are reviewed according to the organization's SOP and department guidance. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. You may develop collaborative relationships with investigators and site personnel to conduct feasibility assessments.

Responsibilities

Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
Ensures allocated tasks are performed on time, within budget and to a high quality standard.
Proactively communicates any risks to project leads and line manager as appropriate.
Performs administrative tasks on assigned trials including timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications, providing documents and reports to internal team members.
Reviews and tracks local regulatory documents.
Analyzes and reconciles study metrics and findings reports.
Assists with clarification and resolution of findings related to site documentation.
Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
Assists with study-specific translation materials and translation QC upon request.
Assists with technical and administrative support for projects in collaboration with internal departments and team members.
Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines.
Ensures that trial status information relating to activities is accurately maintained in the database and current at all times.
Develops and maintains relationship with client local affiliates.
Champions the inclusion of Strategic Collaboration sites into the process.
Conducts on-site feasibility visits (Asia Pac only).
Trains new personnel in processes and systems.
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers, including study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans.
Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.
Assists the project team with the preparation of regulatory compliance review packages.
Supports start-up team in Regulatory submissions.
Works directly with site(s) to obtain documents related to site selection.
Develops site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile.
Ensure current investigator and site staff contact details are appropriately maintained in company systems.
Completes the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel.
Document in real time all communication, attempts and follow up associated with site contact and survey responses.
Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
Works in collaboration with teammates to achieve targeted deadlines for assigned projects.
Communicate with the team and appropriate clinical personnel regarding site issues and risks.
Ensures an efficient, effective plan is in place for site contact and follow up and ensure compliance with the plan and escalates concerns/non-compliance to management.
Acts as the local expert regarding site capacity and experience.
Work with key local personnel to gather knowledge base and recommend additional sites.
Harnesses this knowledge base when performing local tiering of sites.
Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
Contributes to the development and roll-out of global strategic feasibility processes and best practices.
Supports the project team in managing study finances and drives timely and accurate invoicing on site payments, vendor payments, etc.

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Ability to work in a team or independently, as required.
Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
Strong customer focus.
Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines.
Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout.
Excellent English language and grammar skills and proficient local language skills as needed.
Good presentation skills.
Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.

Skills

Administrative support
Technical support
Audit readiness
File reviews
Site activation
Feasibility assessments
Regulatory document tracking
Data analysis
Communication
MS Office proficiency

Location

Remote

Work Type

Onsite (three days per week during the first six months)
Full-time

Experience Level

Associate II

Education Level

High / Secondary school diploma or equivalent
Bachelor's degree preferred

Benefits

Comprehensive benefits
Wellness programs
Employee Assistance Program
Flexible arrangements
Generous leave policies
Option to purchase additional leave
Paid birthday leave
Company paid parental leave
Paid volunteer time
Access to online courses via Thermo Fisher Scientific University Plus
LinkedIn learning
Workshops
Mentorship programs

About the Company

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
We provide critical solutions through innovation.
As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement.
We accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

Equal Opportunity

WGEA Employer of Choice for Gender Equality
EEO/Affirmative Action Employer
Does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Individuals with disabilities will be provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.