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Assists in the design and development of custom edit checks by Gathering requirements for protocol specific implementations of Express in accordance with edit check specifications Writing, validating, and implementing protocol specific edit checks Developing custom reports based on project management requests Importing protocol specific lab data based on customer/laboratory specifications Periodic
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This position manages all aspects of software analysis, development, design, implementation, deployment, and support. Ensures software applications are built with quality while conforming to corporate and regulatory processes and practices by Monitoring team resources to ensure that requirements, design, and development processes are being followed Establishing and monitoring metrics for measuring
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We are looking for a self starter who has experience in building and growing a business with a minimum of five years experience in GI, inflammatory bowel disease (IBD). Clinical trials research experience preferred. Experience with research and publication. Primary Responsibilities Drives strategic market focus and helps obtain market share by Participating in new business opportunities; communica
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BioClinica
- Doylestown, PA / Princeton, NJ
The Sr. Product Manager will be a product owner and strategist for Bioclinica's Software Solutions integration platform which supports core eClinical products such as EDC, CTMS, IRT, etc. This role will be responsible for product strategy, roadmaps and product delivery to drive market growth and commercial success. To be successful you must have the relevant product management background with hand
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Responsible for providing product management leadership, structure, and vision for software products within the business segment to meet established operational and financial goals and objectives Responsible for product strategy, product roadmaps, investment planning to ensure industry leadership, while also understanding cross product prioritization Creating and maintaining the commercial busines
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Serves customers by Advising in the definition of business and technology operations enhancements Maintains operating efficiency and system performance by Recommending, developing, implementing and maintaining new and existing technology infrastructures Acquiring new software and hardware, negotiating service contracts and building relationships with vendors Upgrading current software for differen
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Ensures software applications are accurate, complete and conform to all user, company and regulatory requirements by Tracking all software versions, features, bugs and validation efforts for all software created and/or modified by the Development teams. Developing and utilizing test data sets that support the implementation of test plans and procedures. Creating and executing manual test scripts w
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BioClinica
- Newark, NJ / Audubon, PA / Wilmington, DE / 1 more...
For assigned clients, serves as client champion and ensures successful delivery of contracted services by Maintaining thorough knowledge and understanding of client contracts, deliverables, business practices and key performance indicators. This includes maintaining thorough knowledge of all client agreements (e.g., Service Level Agreement, Governance Agreements, Rate Cards) Maintaining thorough k
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Serves as imaging advisor supporting company operations and initiatives by Providing support for dedicated therapeutic areas, including Input on the trial design, review methodology and quality control of image data Management of processes used to evaluate and enhance the independent review Assess trends in independent review metrics, including Developing benchmarks for reviewer performance Identi
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BioClinica
- Princeton, NJ / Audubon, PA / Newark, NJ
Interpreting clinical data according to standard medical practice, GCP guidelines, protocol and charter definition and according to standard Bioclinica SOPs Completing source documents accurately and promptly, according to the specific charter requirements and following Bioclinica SOPs Correcting entries on source documents and Case Report Forms (CRFs) in a timely manner as needed Participating in
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BioClinica
- Princeton, NJ / Audubon, PA / Newark, NJ
Performs project analysis and administration by Reviewing project protocol documents, charters, imaging manuals, clinical data transfer plans and business requirements Participating in project meetings, conference calls, training sessions and bid defenses as requested Obtaining and tracking clinical study metrics on an individual and global level to identify trends Acting as a liaison with cross f
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BioClinica
- Princeton, NJ / Audubon, PA / Charlotte, NC / 2 more...
Manages all aspects of audits / audit conduct Plans, conducts, and reports audits according to Bioclinica's standard operating procedures (SOPs) and electronic document management system (EDMS) processes. Tracks and/or trends audit issues and/or CAPAs until closure. Provides root cause guidance to CAPA owners and/or conducts root cause analysis when assigned. Champions timely management of quality
Posted Today
Identifies project guidelines and communication needs by Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start up activities and associated documents Defining project plans (i.e. timelines, milestones and limitations for project staff) Establishing project reporting schedules Providing project updates to BD Director, Global Serv
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BioClinica
- Princeton, NJ / Doylestown, PA
Ensures clinical trial databases meet project requirements by Performing all data management deliverables for assigned studies Attending and participating in client meetings as requested Ensures the plan for data management is properly executed by Understanding the requirements for study implementation and data collection Collaborating with project team to develop study specific edit check criteri
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BioClinica
- Princeton, NJ / Audubon, PA / Charlotte, NC / 4 more...
Provides data to clients (internal and external) in functional format by Creating and executing SAS edit check programs Validating edit check programs using standard validation practices and processes Creating, validating and executing SAS programs and macros Utilizing SAS programming skills to provide ad hoc reports (external and internal) Assist in developing programming specifications Assist in
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