Thermo Fisher Scientific

Sr Medical Project Coordinator

Thermo Fisher Scientific • $95K — $115K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN.
  • Over 5 years of clinical safety experience, including clinical research monitoring and pharmacovigilance.
  • Strong knowledge of Good Clinical Practices (GCPs) for medical oversight of clinical trials.
  • Advanced understanding of safety data analysis and coding practices.
  • Proficient in project management and budgeting.

Responsibilities

  • Manage and coordinate medical projects to ensure compliance and optimal performance.
  • Conduct first-pass reviews of safety data using visualization tools to identify trends and issues.
  • Lead the medical monitoring services for clinical projects not contracted for SAE case processing.
  • Create and maintain medical management plans in line with contract requirements.
  • Monitor financial status of projects, including forecasting and team allocations.
  • Address complex project issues with strategic problem-solving and solutions.
  • Represent the company in meetings and collaborations with clients and stakeholders.

Benefits

  • Supportive work-life balance and a healthy work environment.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Join Us as a Senior Medical Project Coordinator

What You'll Do:
The Senior Medical Project Coordinator manages, coordinates and evaluates medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel.
  • Work independently to perform first pass review of safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Review data for safety trends, coding consistencies, and potential follow up with investigator sites. Proactively identify any potential issues and resolve or escalate as appropriate.
  • Review safety data and provide summations for safety review meetings.
  • Review designated sections of aggregate reports.
  • Independently function as the Project Lead for medical monitoring services when SAE case processing has not been contracted. Manage project implementation, coordination, maintenance and close out of assigned studies as applicable. Serve as the primary point of contact for clinical project teams on studies and can act as the alliance level lead on larger alliance/multi-protocol studies.
  • Create and maintain medical management plan(s) on studies (as applicable) and ensure that the processes included in the plan document are reflective of the contract and services requested for studies that have department involvement and those that are standalone studies (ex. MM and/or MPC).
  • Work independently to monitor the project financial status, unit forecasting, actual realization, and team allocations in systems. Coordinate staff projections based on contract values and actual hours used. Escalate any financial and/or operational risks and can attend risk management meetings to discuss.
  • Independently determine hours required for out of scope work for the team and provide this to the finance/study team for contract modifications. Attend meetings to discuss/justify the modification requirements.
  • Resolve complex problems through in-depth evaluation of various factors and offers solutions. May assist management in training and mentoring.
  • Present at business development, client, and investigator meetings and participates in strategy/business development calls. Represent studies at risk management meetings.


Education and Experience Requirements:
  • Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years), to include 5+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)


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:
  • Advanced knowledge of GCPs for medical oversight of clinical trials
  • Knowledge of drug development and safety reporting
  • Advanced knowledge of safety data trending to include coding
  • Working knowledge of biostatistics, data management and clinical procedures
  • Excellent problem solving and critical thinking skills
  • Excellent project management and budget skills
  • Effective mentoring skills and ability to train and lead others
  • Strong oral and written communication skills
  • Strong attention to detail
  • Ability to work in a collaborative team environment
  • Ability to maintain a positive and professional demeanor in challenging circumstances


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.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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