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Project Manager
CACI International
Laurel, MD
Are you ready to shape the future of intelligence systems? CACI is seeking a talented Project Manager to join our team in Laurel, MD.
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Senior Geothermal Consultant Job Details | Black & Veatch Family of Companies
Black & Veatch
Gaithersburg, MD
With flexible ways of working and meaningful development opportunities, you’ll build a career you can be proud to stand behind.
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HN
Product Group Manager
Huntington National Bank
Hagerstown, MD
- $93,000 to $189,000 USD / year
Summary:The Product Group Manager develops and implements the strategic direction, which integrates with corporate strategy, for a product group or geographic region.
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AD
Quality Assurance Specialist - Manufacturing (Rockville, MD)
Antech Diagnostics
Rockville, MD
- $63,000 to $79,000 USD / year
Represent Quality on design and development project teams.
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M
Sr. Manager, Fire Life Safety, US/Canada
Marriott
Bethesda, MD
- $110,400 to $164,000 USD / year
…safety across Marriott’s brands in the US and Canada. The Sr. Manager will engage with cross-functional teams and external partners to support safe and compliant hotel development and…
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Business Travel Account Manager
Marriott
Bethesda, MD
- $23.99 to $38.41 USD / hour
This primary function of the Business Travel (BT) Account Manager is to provide support to their assigned accounts in the BT segment. The position will support the US Account Sales Leader…
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Project Accountant - Remote, US
Bowman
Annapolis, MD
Bowman has an opportunity for a Project Accountant to join our team remotely, preferably in the West Region (California/Nevada).
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Lead Specialist, Performance Marketing
Pearson
Annapolis, MD
This position is also known as: Senior Paid Search Manager; Lead SEM Specialist; Lead Performance Marketing Specialist; Paid Search Lead
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Copeland
Annapolis, MD
The Operations Project Manager will lead and support cross-functional projects within the Operations functions of Copeland, including Manufacturing Operations, Procurement, Supply Chain,…
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Healthcare .NET Senior Application Developer - HNAS
Highmark Health
Annapolis, MD
This job takes the lead in providing more complex application development services typically as part of a project team or in an application support role. Developers analyze, design, code,…
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Technical Program Manager - Child Safety (Legal)
Meta
Annapolis, MD
…organization is looking for an experienced Technical Program Manager who has experience applying technical expertise and organizational skills to drive execution of child safety programs -…
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Analyst, Product Support
SitusAMC
Annapolis, MD
Performs Testing of Inhouse Applications for Project and Support-related activities
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Manager, Partnership Management
Pearson
Annapolis, MD
The Manager, Partner Success leads a team of Partner Success professionals responsible for supporting state, district, and school partners throughout the assessment lifecycle while ensuring…
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Platform Engineer - Remote
SitusAMC
Annapolis, MD
Develop and maintain the in-house CI/CD automation pipeline as an individual contributor on the Cloud development platform team.
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Communications Manager, Long Form Editorial
Meta
Annapolis, MD
…in simple and effective language. Excellent cross-functional project management and communication skills are crucial. You should be able to work collaboratively on concurrent projects,…
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Product Manager – Retirement Services
Cognizant
Annapolis, MD
- $150,000 to $180,000 USD / year
As a Product Manager – Retirement Services, you will make an impact by serving as the strategic bridge between business stakeholders, client leadership, and delivery teams to drive…
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Manager Database Administrator - Remote US
SitusAMC
Annapolis, MD
Work with the project team and business teams to ensure database designs meet project and business requirements
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AT
Senior Technical Program Manager
Akamai Technologies, Inc.
Annapolis, MD
- $119,600 to $215,400 USD / year
Have professional experience as a Project Manager/Program Manager working effectively with cross-functional teams
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Manager, Content Editing
Wolters Kluwer
Annapolis, MD
The Manager, Content Editing leads an editorial team supporting content across the Lexidrug portfolio. This role oversees daily operations, team development, and content quality, ensuring…
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Senior Proposal Manager
Maximus
Annapolis, MD
Maximus is thrilled to announce an opportunity for a Senior Proposal Manager. The primary responsibility of this role is to lead cross‑functional proposal teams, including collaboration…
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Employer Account Executive - Remote
Prime Therapeutics
Annapolis, MD
Manage the end-to-end Request For Proposal (RFP) process for renewing groups, including the development of a contract renewal project plan; proactively analyze contract language and/or…
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Systems Administrator – Kiteworks
SitusAMC
Annapolis, MD
Support infrastructure workstreams on site and project development efforts, providing solution design input, effort estimates, and technical risk assessment during the planning phase.
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Vice President, Cloud Platform Engineer
SitusAMC
Annapolis, MD
…Terraform, AWS Services, Docker, Kubernetes, and familiar with Git development. The Engineer is expected to provide strategy and implement enterprise-scale automation for scalability,…
Added 1 min ago
Construction Engineer, Civil
Washington Metropolitan Area Transit Authority
Chevy Chase, MD
Represents the project manager on designated projects and ensures that facilities and systems are constructed within the established schedule(s) and thoroughly coordinated with operational…
Added 1 min ago
Construction Engineer, Civil
Washington Metropolitan Area Transit Authority
New Carrollton, MD
Represents the project manager on designated projects and ensures that facilities and systems are constructed within the established schedule(s) and thoroughly coordinated with operational…

PPD Development, LP

FSP Sr CRA I

Remote, United States

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Job details

Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
Posting language: English
Posted: Nov 5, 2026

Original job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Join Us as Senior Clinical Research Associate I – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. DESCRIPTION As a Senior Clinical Research Associate I in our FSP model, you will be dedicated to one specific client, acting as a representative of the client while exercising strong communication and collaboration skills. You will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites.

What You'll Do:

Monitors investigator sites with a risk-based monitoring approach.
Applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
Assess investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards.
Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Conducts monitoring tasks in accordance with the approved monitoring plan.
Participates in the investigator payment process.
Ensures a shared responsibility with other project team members on issues/findings resolution.
Investigates and follows-up on findings as applicable.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
Performs QC check of reports generated from CTMS system where required.
Participates in investigator meetings as necessary.
Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
Ensures trial close out and retrieval of trial materials.
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
Conducts on-site file reviews as per project specifications.
Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Facilitates effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.
Responds to company, client and applicable regulatory requirements/audits/inspections.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Contributes to other project work and initiatives for process improvement, as required.

REQUIREMENTS

Education and Experience Requirements:

Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).
Oncology experience preferred.

Knowledge, Skills and Abilities:

A seasoned, experienced professional, with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
Strong critical thinking and problem-solving skills.
Excellent clinical trials monitoring skills; remote and on-site.
Demonstrated understanding of ICH-GCP guidelines, applicable regulations and SOPs.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Demonstrates good judgement in selecting methods and techniques for obtaining solutions.
Strong communication and collaboration skills with ability to interact effectively with investigative sites, clients, and internal teams.
Ability to act as a representative of the client while maintaining professional relationships.
Advanced written and oral communication skills.
Strong organizational skills and attention to detail.
Demonstrated use of computer systems including CTMS and other trial management platforms.
Ability to travel >75% as required for site monitoring activities.

Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience - and where your contributions truly make a difference. Apply today to help us deliver tomorrow's breakthroughs.

Compensation and Benefits The salary range estimated for this position based in Colorado is $90,000.00–$113,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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More about this job

Skills

Clinical research
Clinical trials
Communication skills
Collaboration
Regulatory compliance
Documentation
Google Cloud
Root cause analysis
Critical thinking
Problem solving
Monitor activities
Inspection
Process improvement
Organizational skills
Attention to detail

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