Associate Director - Project Management - FSP - eCOA exp
Associate Director - Project Management - FSP - eCOA exp
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Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of lifechanging therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
The PPD FSP Solution:
PPDs Functional Service Provider division partner with and serve as an extension of our PPD team supporting our customers key functions. We cover customer needs on every level allowing them to do more with less with an uncompromising commitment to quality. We deploy the same toptier talent in ALL engagement models. Exceptionally trained rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
Joining within our PPD FSP functional area allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
Discover Impactful Work:
The AD Project Management eCOA serves as a functional subject matter expert (SME) in the field of electronic Clinical Outcome Assessments (eCOA) driving process optimization standardization and operational excellence across clinical programs. This role collaborates closely with many cross functional departmentsto enhance efficiency and effectiveness in eCOA implementation.
By providing strategic oversight governance and continuous process improvements the succesful candidate will ensure that eCOA solutions are seamlessly integrated fully compliant with regulatory requirements and enhance the patient and site experience to ensure an optimal level of robustness for data captured via eCOA.
A day in the Life:
Serves as the primary contact between the sponsor and the organization at theproject level.
Lead crossfunctional teams in the development optimization and of eCOA frameworks to ensure efficiency compliance and seamless trial .
Serve as the eCOA SME across the organization providing expert guidance throughout the endtoend (E2E) process to ensure best practices and regulatory compliance.
Ensures financial stewardship at a project level by demonstrating an intimate
understanding of the contract resource alignment to budget management of
Out of Scope activity drive the Con Mod process/negotiations and team
to timelines.
Establishes communicates and manages customer expectations to achieve
optimal delivery during the project.
Drives Risk Identification and Issue Resolution at project level (RBQM/RESOLVE).
Ensures project team compliance with organization policies SOPs ICH GCP
regulatory and project specific requirements
Oversee thirdparty vendors for copyright translations and library services ensuring compliance with licensing agreements and regulatory requirements.
Design and implement a comprehensive training program to enhance internal expertise on eCOA processes compliance requirements and industry best practices.
Ensure continuous regulatory inspection readiness maintaining complete documentation (including eCOA training) audit trails and compliance with global regulatory requirements (ICHGCP FDA EMA and industry guidelines).
Keys to Success:
Masters or Bachelors degree in Life Sciences or a related field or equivalent experience.
Minimum 8 years of experience in clinical trials within the pharmaceutical or biotechnology industry with direct eCOA implementation responsibilities.
Proven expertise in system implementation vendor management and process development of eCOA.
Knowledge Skills Abilities
Expert knowledge of eCOA methodologies regulatory guidelines (ICHGCP FDA EMA) and industry best practices.
Deep understanding of eCOA systems technical implementation and operational workflows.
Strong analytical skills and attention to detail to identify and resolve issues proactively.
Ability to work independently and crossfunctionally leading complex initiatives with minimal oversight.
Excellent communication stakeholder management and interpersonal skills.
Fluent in English (written and spoken).
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
May require travel. (Recruiter will provide more details.
Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.
Apply today!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and 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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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Required Experience:
Director
Employment Type
Full-Time
