- Lead the project team to engage major IT and clinical research stakeholders to establish project plans and documentation.
- Define requirements, features, and functionalities of the system.
- Perform Computer Systems Validation, and maintain the solution through the SDLC lifecycle.
- 8+ years as an IT Project Manager supporting clinical trial operations IT systems
- Experience leading project teams in the implementation, configuration, user management, and operation and maintenance of the enterprise-level systems in support of clinical trials research
- Experience working with clinical quality management systems like Master Control QMS
- In depth understanding of clinical trial management lifecycle or technologies used in clinical trials management (EDC, CTMS, QMS, eTMF)
- Experience managing large stakeholder groups and multi-tenant applications, overseeing multiple configurations and business requirements by stakeholder group or tenant
- Experience leading requirements gathering, drafting and coordinating documentation to support GAMP5 Computer Systems Validation and Testing
- Ability to coordinate with project team, vendor, and stakeholders to ensure software complies with both research and regulatory requirements for each business need
- Ability to coordinate and lead user training, train-the-trainer sessions, and lead the team in the development of all user reference materials for all user-types and businesses
- Demonstrated in-depth knowledge of GxP, ICH guidelines, and regulatory requirements for clinical research
- Proven ability to maintain project deliverables and schedule and provide direct feedback on status updates to Program and client leadership
- Bachelor's Degree or related experience in an IT and health field
- Experience with migrating on-premise solutions to the cloud or to vendor-hosted Software-as-a-Service
- Experience doing large-scale data migrations of controlled documentation in support of clinical trials research and operations
- Knowledge of the SDLC and HHS EPLC lifecycle and deliverables
- Competitive benefits including Health Insurance, 401K with match, Paid Time Off and more
- Results driven culture that embrace our core values
- Rewarding work contributing to our Nation's mission critical programs
-
Project Manager
2 weeks ago
Doyle Construction Company Rockville, United States**Overview** · At Doyle, our primary objective is to deliver exceptional service catered to our clients' specific goals and concerns. Our project teams deliver top quality work through a hands-on, collaborative process while keeping our clients' best interests our absolute focus ...
-
Project Manager
2 weeks ago
James G. Davis Construction Rockville, United StatesDAVIS Construction is the largest general contractor that solely serves the MidAtlantic region, with offices in Rockville, MD and Philadelphia, PA. Voted on by our employees, DAVIS has been consistently recognized as a Best Place to Work by the _Washington Business Journal _since ...
-
Project Manager
1 week ago
Sekon Rockville, United States**SeK**ON** has an opportunity for a **Project Manager** to join our talented and innovative team supporting the **Substance Abuse and Mental Health Services Administration (SAMHSA).** · With over 25 years of mission-focused success, **SeK**ON** delivers cultural, operational, an ...
-
IT Project Manager
5 days ago
YSI Rockville, United States**Position Title**:Project Manager** · **Location: Washington, DC/ Telework** · **Yakshna Solutions, Inc**., **(YSI)** is a CMMI Level 3 assessed, ISO 9001, 20000:1, 27001 certified, woman-owned small business enterprises, headquartered in Herndon, Virginia, USA. YSI provides pro ...
-
IT Project Manager
1 week ago
US National Institutes of Health Montgomery County, MD, United States**Duties**: · - Managing cross-functional teams responsible for delivering defined project outputs on time, within budget and with quality results. · - Planning, organizing, monitoring and overseeing one or more projects to meet defined requirements or specifications. · - Creatin ...
-
Project Manager
2 weeks ago
Axle Rockville, United States(ID: · **Benefits**: · - 100% Medical, Dental & Vision Coverage for Employees · - Paid Time Off (Including Holidays) · - Employee Referral Bonus · - 401K Match · - Tuition reimbursement and professional development opportunities · - Flexible Spending Accounts: · - Healthcare (FS ...
-
Project Manager
12 hours ago
BETAH Associates Rockville, United StatesBETAH Associates seek a highly skilled and motivated **Project Manager** to lead our team in managing a project team in support of a government client. This role is pivotal in ensuring the effective and efficient management of program operations, delivering exceptional results, a ...
-
Project Manager
1 day ago
BETAH Associates Rockville, United StatesBETAH Associates is a professional services firm seeking a **Project Manager (Health Projects) **to lead a project team at federal health agency. · **Essential Duties & Responsibilities** · **Project Planning and Strategy**: · Develop comprehensive project plans outlining goals, ...
-
Project Manager
1 day ago
Software Productivity Strategists Rockville, United States**Location: Rockville, MD**: · **Category: Cloud**: · **Last Date: **: · **Education**: · Relevant Bachelors Degree from an accredited college or university. Project management certification is preferred. · **Qualification**: · - Knowledge and experience executing large scale imp ...
-
Project Manager Ii
2 weeks ago
Meso Scale Diagnostics, LLC. Rockville, United States: · This position is responsible for the overall planning, execution, and reporting of a portfolio of projects and programs; overseeing the dependencies between interconnected projects and managing portfolio-level plans to achieve strategic objectives. The incumbent will manage a ...
-
Assistant Project Manager
2 weeks ago
Doyle Construction Company Rockville, United StatesAt Doyle, our primary objective is to deliver exceptional service catered to our clients specific goals and concerns. Our project teams deliver top quality work through a hands-on, collaborative process while keeping our clients' best interests our absolute focus at all times. Wi ...
-
Assistant Project Manager
1 week ago
Manders Companies Rockville, United StatesManders Companies is a full-service interior/exterior painting and renovation company dedicated to high-quality service to our customers in the construction and property management industries. We are looking to add an energetic, conscientious and detail-oriented individual who en ...
-
Assistant Project Manager
2 weeks ago
Doyle Construction Company Rockville, United StatesAt Doyle, our primary objective is to deliver exceptional service catered to our clients' specific goals and concerns. Our project teams deliver top quality work through a hands-on, collaborative process while keeping our clients best interests our absolute focus at all times. Wi ...
-
Project Developer Manager
3 days ago
STANDARD SOLAR INC Rockville, United StatesEssential Duties and Responsibilities: · - Support greenfield development activities of distributed-scale solar and energy storage projects from site control feasibility to the start of construction · - Manage and lead development activities by working with internal teams in area ...
-
Assistant Project Manager
2 weeks ago
James G. Davis Construction Rockville, United StatesThe Assistant Project Manager is responsible for assisting the Project Management Team with the daily · management, coordination, and execution of the construction process. This role will assist with safety · management, quality, cost management, contracting, scheduling, estimati ...
-
Assistant Project Manager
6 days ago
Shapiro & Duncan Rockville, United States**COMPANY SUMMARY**:A third generation family-owned business, Shapiro & Duncan has been serving customers in DC, Maryland and Virginia since 1976. The company is known for their award-winning company culture and complex commercial, government and institutional design-build projec ...
-
Assistant Project Manager
2 weeks ago
Liberty Construction Rockville, United StatesSalary: $75k · Location: Rockville MD · **Job description** · **Company** · Liberty Construction is a General Contractor that specializes in building medical and dental interiors for practice owners in the DMV region. We are a small, 10 year old company looking to expand with pro ...
-
Construction Project Manager
1 week ago
MN International Enterprises Rockville, United States**QUALIFICATIONS**: · **Knowledge, Skills and Abilities**: · - **5+ years of experience as a Project Manager in commercial construction, 3 of which may be Assistant Project Manager experience.**: · - **High school diploma or equivalent required, college degree preferred.**: · - K ...
-
Project Manager- Construction
1 week ago
Blueprint Staffing Derwood, United StatesBenefits include health insurance · - 401k w/ match up to 5% · - Two weeks of PTO · - A Construction design-build firm is looking for an experienced full-time project manager in the Metropolitan Washington Area._ · **Project Manager Responsibilities**: · Project Manager works wit ...
-
Distribution Project Manager
1 day ago
Thermo Fisher Scientific Rockville, United StatesLocation: Onsite Breinigsville, PA office · **Responsibilities**: · - Manages the delivery of all technical and service aspects of projects and studies for clients. · - Determines the preliminary design of the study and evaluates and understands the study. · - Serves as the inter ...
Clinical Systems Project Manager - Rockville, United States - Blu Omega
Description
We are looking for an IT Project Manager that will lead a cross-functional team to implement Commercial-off-the-Shelf (COTS) enterprise-level systems.
This role is onsite for 3 days per week for the first 90 days, and then 1 day per week long term.
Responsibilities:
Experience:
Nice to Haves:
What Blu Omega Can Offer You:
Blu Omega is a Woman Owned Small Business Federal Technology services firm headquartered in Washington DC and supporting clients nationally. We provide Technology solutions for enterprise and government customers. Our team has a past performance in a diverse range of programs including those for Data Management, Cloud/Infrastructure, Software Development and Enterprise Applications.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
