FSP Sr. Medical Affairs Coordinator at Thermo Fisher Scientific in Raleigh, North Carolina

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



At Thermo Fisher Scientific, you'll 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 life-changing 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.



Division Specific Information



Our global Clinical Research Group (CRG) colleagues within the Functional Service Partnership (FSP) solutions area provide support for clinical trials during feasibility, study start up, maintenance, close out, and database lock, depending on the client's needs. Client-dedicated Clinical Trial Coordinators (FSP CTCs) work directly with clients to provide administrative and technical support by performing day-to-day functions within the client organization to support clinical trial activities.


In the FSP CTC role, you will represent PPD, part of Thermo Fisher Scientific, while working alongside the client, as a partner, providing a specific service. Tasks can include providing administrative and technical support to the client study team; supporting client audit readiness by ensuring client systems are accurate and up to date; providing administrative support for site activation activities; and managing assigned service providers and/or vendors. FSP CTC roles and responsibilities may vary based on client needs.



A Day in the Life:



Coordinates with study team during startup, maintenance, and closeout activities to include collection, review, and submission of documents to regulatory authorities Manages and contributes to the electronic Trial Master Files (eTMF) during feasibility, study startup, maintenance, and closeout activities (e.g., collecting and filing documents, uploading study team lists, adding/updating study site information, study milestones and other important data) Performs eTMF quality and completion checks and initiates follow-up on resolutions when needed Assists with feasibility and site selection activities Manages study system access for study team, site staff, and service providers/vendors


Attends internal/external meetings and supports scheduling, agenda and meeting minutes creation/distribution Creates, maintains, reviews and/or distributes study trackers, forms, newsletters, memos to study teams, sites and service providers/vendors Assists study lead with oversight of the client's service provider(s) to ensure assigned activities are completed accurately and on time (e.g., system completeness, product vendor(s) and site management) Assists with administrative requests for entering purchase orders, change orders and running financial reports, with oversight of study lead May assist with coordination of trial/site insurance, tracking of study supplies and/or shipments of drug supply Attends and/or assists in preparation for in-person meetings, such as Kick Off Meetings (KOMs), Investigator Meetings (IMs), or client Face to Face meetings May assist with additional client administrative projects and tasks as needed, such as supporting onboarding of new study team members.


• Supports activities such as contracting, and vendor onboarding activities by coordinating with Legal for review of CDAs and contracts and coordinating with Finance to execute purchase orders and contracts, for Medical Affairs.


• Ensure vendor set up and purchase order creation process is conducted in compliance with the company's SOP.


• Process all ESR contracts and additional MA&EG project Statements of Work (SOW)


and Purchase Order (PO) requests in a timely manner.


• Act as primary point of contact for MA&EG External Sponsored Research (ESR) argenx mailbox and portal.


• Triage, review, respond and/or route ESR inquiries or physician requests based on standard response letters and defined program process flows.


• Collaborate with internal and external stakeholders to ensure HCPs queries or issues are resolved in a timely manner and tracked accordingly.


• Create and track custom ESR response letter, correspondence and follow-up communications for documentation and analysis as required.


• Ensure relevant ESR proposal milestones and data are systematically tracked, contribute to dashboards in line with argenx and industry requirements.


• Proactively identify areas for process improvement.


• Deliver reports to enable resource planning and material review related to requests, number of system entries and inquires.


• Provide operational and logistical support as needed to support MA&EG team projects.



PU
R
P
O
S
E OF THE FUNCTION



The Integrated Medical Affairs and Evidence Generation (MA&EG) group delivers ambitious, patient-focused cross-regional and cross-indication medical strategies, driving data generation and dissemination, to maximise patient benefit from argenx products.


This role will collaborate closely with MA&EG project teams, capability teams and the


ESR team to:


• Engage with project teams and vendors to establish and process and track SOWs, WOs and contracts through completion.


• Process and track executed contracts through to vendor and purchase order set up within internal systems to generate a PO.


• Act as project coordinator for the MA&EG project teams, capability project teams and the ESR program in support of internal mailboxes, such as the ESR mailbox.


• Triaging requests such as SOWs, POs and ESR proposals to the appropriate internal teams and stakeholders.


• Processing proposals and tracking projects in systems.


• Drafting project team agendas and minutes, such as ESR Committee agendas, minutes, and archiving them working in partnership with the MA&EG project leads and ESR leads.



Keys to Success:




Education

• • Bachelor's Degree in healthcare or life sciences required
  
  
  • 5+ years industry experience
  
  

Experience

• Previous experience that provides the knowledge, skills and abilities to perform the job.


• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Good organizational skills and strong attention to detail, with shown ability to handle and prioritize/reprioritize multiple tasks efficiently and effectively


• Shown ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency


• 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


• Good English language and grammar skills and proficient local language skills as needed


• Good computer skills, including knowledge of Microsoft Office and/or Google Suite


• Ability to obtain knowledge and master all clinical trial database systems (e.g., Veeva, RAVE, SIP)


• Ability to identify and escalate risk as appropriate


• Ability to quickly learn and adapt to client processes and systems (as applicable)


• Ability to work in a team or independently as required


• Strong customer focus


• Self-motivated, positive attitude, and good social skills


• Effective oral and written communication skills


• Essential judgment, independent thinking, and decision-making skills


• Capable of accurately following project work instructions


• • Strong ability to network and build strategic partnerships with internal and external stakeholders, fostering collaboration to drive projects forward.
  
  
  • Ability to understand regional variation and regulations impact on process and procedures to ensure compliance with internal SOPs and external laws.
  
  
  • Highly proficient in operational execution, with a keen attention to detail and a commitment to tracking, measuring, and reporting progress.
  
  
  • Excellent verbal and written communication skills
  
  
  • Strong advocate for cross-functional collaboration, recognizing and leveraging the strengths of diverse teams.
  
  
  • Adaptable and effective both as a team player and when working independently.
  
  
  • Proven ability to work independently, highly organized and effective in handling multiple detail-oriented projects in a fast-paced environment and is proactive to anticipate challenges and/or resolve problems.
  
  
  • Strong administrative and computer skills, including Word, Excel, and PowerPoint;
  
  
  familiarity with database functionality (back-end and user interface)
  
  
  • Ability to identify opportunities to improve efficiency and to respond effectively to the needs of the business.
  
  
  • Experience in executing on key objectives with a cross-functional scope.
  
  
  
  

Physical Requirements/Working Environment



Thermo Fisher Scientific 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 comprehensive 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.


• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.


• Travel may be required based on client needs.

#CRAdrive


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 100,000+ 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! http://jobs.thermofisher.com


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


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