Clinical Data Manager

Clinical Data Manager

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pinpointhq.com / en / postings / 97839302-bbf2-44a8-9f39-8228ec01363c","location" : " / en / postings / 97839302-bbf2-44a8-9f39-8228ec01363c","scheme" : "https","host" : "exactech.

pinpointhq.com","port" : null,"pathname" : " / en / postings / 97839302-bbf2-44a8-9f39-8228ec01363c","search" : null,"httpAcceptLanguage" : "en-US","serverSide" : false Responsible for the development, implementation, and management of databases and related data systems used to support clinical studies across Exactechs businesses.

Ensure complete, accurate and consistent data is reported as required in a timely manner to regulatory bodies and for use in presentations and publications.

Identify any areas requiring improvement in Exactechs clinical data management practices and implements solutions. "htmlString" : " u003cdiv u003e n u003c! block u003eResponsible for the development, implementation, and management of databases and related data systems used to support clinical studies across Exactechs businesses.

Ensure complete, accurate and consistent data is reported as required in a timely manner to regulatory bodies and for use in presentations and publications.

Identify any areas requiring improvement in Exactechs clinical data management practices and implements solutions. u003c / div u003e","featureFlags" : "job templates" : "enabled" ,"companySettings" : "edit offer before send" : true,"advanced search" : true,"facebook advert" : false,"bulk download" : false,"move to hired on offer acceptance" : true,"bulk email job seekers" : false,"workflow automation" : true,"cronofy enterprise connect" : false,"job requisition management" : true,"essential cookies only" : false,"use company from address" : true,"semi private comments" : false,"additional statuses" : false,"multiple company themes" : true,"strict ofccp compliance" : false,"grouped jobs" : false,"move to any job" : false,"remove logo from email template" : false,"candidate job preferences" : false,"automatically reject referrals" : false,"indeed feed stages" : false,"variable sign off signatories" : true,"react select on external jobs" : false,"monitor with rum" : false,"restricted cronofy oauth scope" : false,"application national identifiers" : false,"allow inactive structures" : true,"visible other applications" : false,"allow editing job requisition fields" : false,"two column sidebar" : false,"multiple job postings" : true,"max applications" : false,"group interviews" : false,"create requisitions for existing jobs" : true,"team rejection notification" : false,"send pdf copy of application" : false,"disable indeed feed" : false,"vonq v2" : true,"redirect to custom subdomain" : true,"add cc and bcc to email" : false,"allow creating company teams" : false,"manually send offers" : false,"private calendar events" : true,"candidate details in offer header" : false,"show date in offer header" : true,"show job seekers in all candidates" : false,"talent pipeline" : true,"anonymous screening" : true,"candidate surveys" : true,"task management" : true,"offer management" : true,"referral management" : true,"advanced reporting" : true,"allow cover letters" : false,"location city state" : false,"dei reports" : false,"accessible date and phone" : false,"enable redaction" : true,"internship programme" : false,"document templates on stage" : true,"stage visibilities" : false,"onboarding v2" : false,"limit onboarding to hired candidates" : false,"personal details auto update" : true,"group assessments" : false,"enforce all offer fields required" : false,"resume parsing" : true,"custom job posting locations" : false,"offer splitting" : false ,"enabledLocaleKeys" : "en","es","fr" ,"userRoles" : null,"onboardingSettings" : "isOnboardingEnabled" : false Department Clinical Affairs Employment Type Full Time Location Gainesville, FL Workplace type Fully remote

Key Responsibilities

• Lead the clinical data operations for Exactech to provide high quality clinical data management deliverables.
• Propose and establish best practices and ongoing strategies / needs for clinical data management. Educate and mentor team members on clinical data management best practices.
• Improve methods to organize clinical database information for effective analysis and evaluation of clinical data based on needs of the customer (e.

g., regulatory bodies, clinical investigators).

• Execute the assessment, project planning, design, documentation, testing, and implementation of data collection systems and processes, including, but not limited to : source documents, case report forms, electronic data capture systems, databases, and / or data reporting systems in accordance with good data management practices, and all applicable regulations, guidelines, procedures and company policies.
• Act as a liaison and primary point of contact for all data management related issues and concerns, across Exactechs global businesses.
• Ensure data capture and maintenance will effectively meet the requirements of the protocol, expected project deliverables, and biostatistician requirements (if applicable).
• Coordinate and oversee all reporting activities to key stakeholders (within and outside the organization) : Provide periodic data queries, reports and data summaries to Regulatory, Exactech management, Clinical Project Managers, and / or external team members as requested.
• Know and apply Exactechs Quality Management System and appropriate federal and international standards, including Good Clinical Practices.
• Support other employees, teams, and sales personnel as necessary.
• Practice Exactech Values.

htmlString" : " u003cul u003e n u003cli u003e n u003c! block u003eLead the clinical data operations for Exactech to provide high quality clinical data management deliverables.

u003c / li u003e n u003cli u003e n u003c! block u003ePropose and establish best practices and ongoing strategies / needs for clinical data management.

Educate and mentor team members on clinical data management best practices. u003c / li u003e n u003cli u003e n u003c! block u003eImprove methods to organize clinical database information for effective analysis and evaluation of clinical data based on needs of the customer (e.

g., regulatory bodies, clinical investigators). u003c / li u003e n u003cli u003e n u003c! block u003eExecute the assessment, project planning, design, documentation, testing, and implementation of data collection systems and processes, including, but not limited to : source documents, case report forms, electronic data capture systems, databases, and / or data reporting systems in accordance with good data management practices, and all applicable regulations, guidelines, procedures and company policies.

u003c / li u003e n u003cli u003e n u003c! block u003eAct as a liaison and primary point of contact for all data management related issues and concerns, across Exactechs global businesses.

u003c / li u003e n u003cli u003e n u003c! block u003eEnsure data capture and maintenance will effectively meet the requirements of the protocol, expected project deliverables, and biostatistician requirements (if applicable).

u003c / li u003e n u003cli u003e n u003c! block u003eCoordinate and oversee all reporting activities to key stakeholders (within and outside the organization) : Provide periodic data queries, reports and data summaries to Regulatory, Exactech management, Clinical Project Managers, and / or external team members as requested.

u003c / li u003e n u003cli u003e n u003c! block u003eKnow and apply Exactechs Quality Management System and appropriate federal and international standards, including Good Clinical Practices.

u003c / li u003e n u003cli u003e n u003c! block u003eSupport other employees, teams, and sales personnel as necessary. u003c / li u003e n u003cli u003e n u003c! block u003ePractice Exactech Values.

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Skills Knowledge and Expertise

Education :

High School Diploma or GED required. Associate and / or Bachelors Degree from an accredited institution preferred

Experience :

• Minimum 5 years relevant experience in clinical data management
• Experience in relational database development preferred
• Experience with SAS or SQL programming preferred
• SCDM Certification preferred
• Knowledge of applicable federal and international regulations and guidelines required
• Medical device industry experience preferred

Functional / Technical Knowledge, Skills and Abilities Required :

• Detail-oriented and strong organizational skills
• Familiarity with data acquisition platforms (EDC)
• Firm understanding of biostatistical concepts
• Strong data analysis skills
• Creative problem-solving and critical thinking skills
• Strong interpersonal communication skills
• Working knowledge of MS Office productivity software (e.g. Access, Word, Excel, PowerPoint)

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Associate and / or Bachelors Degree from an accredited institution preferred u003c / li u003e u003c / ul u003e u003cdiv u003e n u003c! block u003e u003cstrong u003eExperience : u003c / strong u003e n u003c / div u003e u003cul u003e n u003cli u003e n u003c! block u003eMinimum 5 years relevant experience in clinical data management u003c / li u003e n u003cli u003e n u003c! block u003eExperience in relational database development preferred u003c / li u003e n u003cli u003e n u003c! block u003eExperience with SAS or SQL programming preferred u003c / li u003e n u003cli u003e n u003c! block u003eSCDM Certification preferred u003c / li u003e n u003cli u003e n u003c! block u003eKnowledge of applicable federal and international regulations and guidelines required u003c / li u003e n u003cli u003e n u003c! block u003eMedical device industry experience preferred u003c / li u003e n u003c / ul u003e u003cdiv u003e n u003c! block u003e u003cstrong u003eFunctional / Technical Knowledge, Skills and Abilities Required : u003c / strong u003e n u003c / div u003e u003cul u003e n u003cli u003e n u003c! block u003eDetail-oriented and strong organizational skills u003c / li u003e n u003cli u003e n u003c! block u003eFamiliarity with data acquisition platforms (EDC) u003c / li u003e n u003cli u003e n u003c! block u003eFirm understanding of biostatistical concepts u003c / li u003e n u003cli u003e n u003c! block u003eStrong data analysis skills u003c / li u003e n u003cli u003e n u003c! block u003eCreative problem-solving and critical thinking skills u003c / li u003e n u003cli u003e n u003c! block u003eStrong interpersonal communication skills u003c / li u003e n u003cli u003e n u003c! block u003eWorking knowledge of MS Office productivity software (e.

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