Senior Clinical Data Manager

1 month ago

Bridgewater, United States Meet Full time

SUMMARY

Serve as primary Clinical Data Management (CDM) contact for Project Team(s), including CROs and other contractors, in the development and execution of multiple clinical trials (in all clinical phases) related to pharmaceutical product development and registration.Responsibilities will include but are not limited to:

Review and understand clinical study protocols

Review and approve Case Report Forms, Edit Checks, and Case Report Form Completion Guidelines

Review and approve Data Management Plans

Review and provide input to Statistical Analysis Plans and IRT specifications

Perform and approve integration with other databases and UAT for EDC and IRT systems

Work closely with clinical trial managers, Medical directors, and Biostatisticians and provide efficient data management support to the study team

Work with internal study teams and CROs to define key data items per study for review

Perform weekly reviews of data listings/reports to assess site performance, data quality, protocol deviations, and cleaning status and inform leadership and CROs of any issues

Proactive in identifying data issues, queries, and involve clinical and/or medical team members on data identification/ trending in question.

Provide support to CROs for CDM outsourced activities, to include but not limited to study team teleconferences

Monitor CRO CDM metrics and KPIs

Assist in vendor selection, where applicable

Assist in the development of departmental SOPs and/or process documents

Take initiative to assist in the further development of department processes and procedures

Keeps abreast of CDM/operations trends, regulations and policies

Handle internal data requests, as appropriate

RESPONSIBILITIES

Although it is anticipated that the incumbent’s responsibilities will be varied in nature, the following outlines the expected basic job responsibilities at the clinical study level.

Pre-Study

Contribute to clinical contract research organization (CRO) identification, validation and selection

Support study budget finalization and the CRO contracting process

Work closely with other colleagues within Clinical Operations and the CRO data manager/team on clinical study plan development

Accountable for setup of edit checks, integrations, and EDC systems, including support for IRT setup

Peri- and Post-study

Oversight of CRO DM activities for assigned clinical studies and associated timelines

Attend and contribute to all relevant study cross-functional meetings

Work with the CRO Data Manager and study team to ensure timely progress reporting and issue escalation

Review and approve necessary CDM study documents created by CROs, vendors or other service providers. Report deviations of concern

Review and assist with development of Safety documents

Define and maintain a master list of key study performance metrics (i.e. endpoint data) in collaboration with the clinical CRO data manager

Review, create, and provide weekly metrics for data management to support timelines, query resolution, and data quality (i.e. endpoint data) for any interim analysis and DB lock

Collaborate with Clinical, CRA, and CROs to ensure timelines, site performance, and data quality expectations are met

Contribute to lessons learned on study and clinical CRO performance


QUALIFICATIONS

Requires 10+ years of proven data management experience and management of CROs

Demonstrable experience in all phases of clinical trials and a working knowledge of typical computer systems used in data management (i.e. EDC, including IRT, etc).

Excellent interpersonal and communication skills (written and verbal)

Ability to understand and convey information to audiences of different backgrounds

Understanding of current pharmaceutical industry practices, guidelines, and applicable laws and regulations

Ability to work independently and in teams

Familiarity with Microsoft office

Must be able to perform all essential functions of the position, with or without reasonable accommodation


EDUCATION

Bachelor’s degree in a scientific or related discipline

Master’s degree or clinical professional affiliations preferred

  • SAP Senior Master Data Governance Analyst

    1 month ago

    bridgewater, United States Bausch & Lomb Full time

    Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.Our comprehensive portfolio of over 400 products is fully...

  • Senior Care Professional

    3 weeks ago

    Bridgewater, New Jersey, United States Sunrise Senior Living Full time

    Sunrise Senior Living is a pioneer in senior care, dedicated to enhancing the lives of our residents through exceptional services and support. As a Care Manager, you will play a vital role in delivering personalized care and creating meaningful experiences for our seniors.About the OpportunityJoin our dynamic team and contribute to the well-being of our...

  • Senior Data Engineer with Snowflake

    1 day ago

    Bridgewater, United States Comprehensive Resources Inc Full time

    Job DescriptionExperienced Data management specialist responsible for developing, overseeing, organizing, storing, and analyzing data and data systemsParticipate in all aspects of the software development lifecycle for Snowflake solutions, including planning, requirements, development, testing, and quality assuranceWork in tandem with our engineering team to...

  • Senior Data Engineer/Data Bricks Engineer

    4 weeks ago

    Bridgewater, United States Canyon Associates Full time

    MUST BE WILLING TO GO ONSITE ON AN AS NEEDED BASIS/OPEN TO 1 DAY A WEEKMUST LIVE IN THE TRI-STATE AREA/NO RELOCATION AVAILABLE AND NO RELOCATING OPTIONYOU MUST BE ACTIVELY LOCAL TO THE BRIDGEWATER NJ LOCATIONYOU MUST BE A US CITIZEN OR GREENCARD, NO OTHER WORK STATUS IS AN OPTIONMUST HAVE STRONG SKILLS IN DATABRICKS/MUST BE ACTIVELY CERTIFIED IN...

  • Senior Financial Analyst

    5 days ago

    Bridgewater, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are in search of a Senior Financial Analyst to assist our client in Bridgewater, NJ. As a Senior Financial Analyst, you will serve as a crucial link between the Director of Finance and the Developmental Team in a nonprofit hospital and school for individuals with medically complicated developmental disabilities. The role...

  • Data Lake Software Engineer

    2 months ago

    Bridgewater, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Data Lake Software Engineer, working in Pharmaceuticals and Medical Products industry in 55 Corporate Drive, Bridgewater, New Jersey, 08807, United States. Job description: Work with Data Scientists, Software Engineers...

  • Data Architect

    4 weeks ago

    Bridgewater, United States Sogeti Full time

    The Data Architect will be responsible for:Exploration of the data footprint left behind by risk-related activities in different domainsCreating a data model on the conceptual and logical levels that incorporates the discovered entities and relationshipsCreating a semantic layer that allows managing and utilizing the necessary metadata (e.g., data...

  • Senior Sustainability Advisor

    2 weeks ago

    Bridgewater, United States Cognizant North America Full time

    Sustainability Advisor Level: Senior Manager (US) Background Are you passionate and experienced in working on challenging projects in carbon emissions modeling, sustainability/ESG reporting, sustainable supply chain and circular business models? Do you like to identify opportunities for transformation and drive change? Are you passionate about technology...

  • Senior SAP SD Consultant

    20 hours ago

    Bridgewater, United States Crescens Full time

    Job Title: Senior SAP SD Consultant Location: Bridgewater, NJ (100% ONSITE) Duration: 4 MonthsJob Description: Responsible for coordinating in building, managing and maintaining a repeatable data load and migration process for SAP S4 Hana implementations and work with the client data lead in managing the Data Migration team responsible for identifying,...

  • Senior Network Engineer

    3 weeks ago

    Bridgewater, United States iconectiv Full time

    #Location - US Remote - Dallas, TX or Bridgewater, NJ locations only About iconectiv Your business and your customers need to confidently access and exchange information simply, seamlessly and securely. iconectiv's extensive experience in information services, digital identity and numbering intelligence helps you do just that. In fact, more than 5K...

  • Senior Manager, Regulatory Affairs

    1 month ago

    bridgewater, United States EUSA Pharma Full time

    This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased...

  • Senior Research Manager, Biotransformation Platform

    4 months ago

    Bridgewater, United States Ingredion Full time

    Have a passion for the biotechnology and being a driving force in our pursuit of advancing the boundaries of biotransformation? Ingredion is looking for a Senior Manager, Biotransformation to play a pivotal role in guiding the Biotransformation Platform and overseeing the team and its diverse activities. You will manage key development and commercialization...

  • Data Reporting Analyst

    3 weeks ago

    Bridgewater, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are offering a contract for a dedicated Data Reporting Analyst position in New Brunswick, New Jersey. As a Data Reporting Analyst, you'll play a crucial role in gathering and interpreting data, generating insightful reports, and collaborating closely with stakeholders to identify trends and tackle complex business...

  • Data Reporting Analyst

    3 weeks ago

    Bridgewater, United States Robert Half Full time

    Job DescriptionJob DescriptionWe are offering a contract for a dedicated Data Reporting Analyst position in New Brunswick, New Jersey. As a Data Reporting Analyst, you'll play a crucial role in gathering and interpreting data, generating insightful reports, and collaborating closely with stakeholders to identify trends and tackle complex business...

  • Data Solution Architect

    5 months ago

    Bridgewater, United States Omni Inclusive Full time

    Detailed JD (Pl share the Detailed Description, 1 liner JD will not work) Keywords - MS Azure platform, Data Bricks Roles and Responsibilities • Solutions Architect for a Supplier Master Data Management system built on the APEX platform. The candidate must have • At least 10+ years of experience in MDM area specifically on Oracle Apex platform • The...

  • Lead Data Engineer

    6 days ago

    Bridgewater, United States CV Library Full time

    Title: Lead Data EngineerLocation: Bridgewater, NJ (hybrid schedule)Duration: 6 months plusThese are the keys for this role :Life Sciences (Pharma, Biotech etc.)Python is a must.Snowflake Platform is a must.Exposure to digital data (social, web activity, etc.) is helpful."Ownership is a must and has been lacking in the resources who have been...

  • Certified Care Professional Wanted for Assisted Living Community

    3 weeks ago

    Bridgewater, New Jersey, United States Sunrise Senior Living Full time

    Job OverviewSunrise Senior Living is committed to delivering exceptional care and services to seniors. We are seeking a dedicated and compassionate Care Manager to join our team.As a Care Manager, you will be responsible for providing high-quality care and services to a consistent group of residents in our assisted living and reminiscence neighborhoods.

  • Senior Network Engineer

    7 days ago

    Bridgewater, United States iconectiv Full time

    #Location - US Remote - Dallas, TX or Bridgewater, NJ locations only About iconectiv Your business and your customers need to confidently access and exchange information simply, seamlessly and securely. iconectiv's extensive experience in information services, digital identity and numbering intelligence helps you do just that. In fact, more than 5K customers...

  • Senior Office Manager

    3 weeks ago

    Bridgewater, Massachusetts, United States Lineage Logistics Full time

    Job SummaryWe are seeking a highly skilled and experienced Senior Office Manager to lead our customer service team. This is an excellent opportunity for individuals who thrive in fast-paced environments, possess strong leadership abilities, and have a passion for delivering exceptional customer experiences.

  • Lead Data Engineer

    3 weeks ago

    Bridgewater, United States Aloden, Inc. Full time

    Title: Lead Data Engineer Location: Bridgewater, NJ (hybrid schedule) Duration: 6 months plus These are the keys for this role : Life Sciences (Pharma, Biotech etc.) Python is a must. Snowflake Platform is a must. Exposure to digital data (social, web activity, etc.) is helpful. "Ownership" is a must and has been lacking in the...