Job Closed

This listing is no longer active.

Associate Director, Clinical Data Management

DirectorDirectorFull TimeRemoteSeniorTeam 1,001-5,000Since 1999H1B SponsorCompany SiteLinkedIn

Location

Belgium

Posted

157 days ago

Salary

0

Seniority

Senior

Bachelor Degree10 yrs expEnglish

Job Description

Associate Director, Clinical Data Management

Genmab

• Drive the implementation of standardized and consistent data management activities across the portfolio • Provide strategic leadership and subject matter expertise in the development, implementation, and governance of CRF standards and data management systems • Act as a subject matter expert (SME) for clinical data standards, including eCRF design, edit checks, visit structures, and controlled terminology • Lead the design and maintenance of standard CRFs, metadata libraries, and configuration templates within EDC platforms (e.g., Medidata Rave) • Collaborate cross-functionally with stakeholders such as Data Management, Biostatistics, Programming, Trial Strategy & Delivery (TSD), and Medical • Oversee change control processes, version management, and lifecycle governance of CRF components within the Global Library • Provide oversight and expert guidance on study build strategy and configuration • Serve as a senior escalation point for issues related to form design, standards deviations, or system configuration inconsistencies • Mentor and support team members, including Managers and Senior Managers

Job Requirements

  • Bachelor's degree in science or related area (or equivalent)
  • 10+ years of Industry Related Experience in clinical data standards, electronic data capture (EDC) systems, clinical data management, or related functions within the pharmaceutical, biotechnology, or CRO industry
  • Foundational knowledge of data standards and metadata management, including familiarity with industry frameworks such as CDISC (CDASH, SDTM) and controlled terminology
  • Proven expertise in the development, deployment, and governance of CRFs, edit checks, visit structures, and controlled terminology, particularly within oncology trials
  • Experience in managing and mentoring staff within a technical function; people management or functional leadership experience strongly preferred
  • Strong project leadership and systems oversight skills
  • Skilled in identifying risks, resolving form and system-level issues, and making sound decisions in a complex, matrixed environment
  • Experience with clinical trials and the drug development process
  • Significant experience leading data management activities in clinical trials
  • Advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation
  • Advanced understanding of DM strategy
  • Experience with CDISC (SDTM); as well as data collection requirements in clinical trials
  • Experience working on early and late-stage submissions as per local/regulatory requirements
  • Experience working in and leading cross-functional teams

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

Related Categories

Related Job Pages

More Director Jobs

Orange Barrel Media logo

Associate Development Director

Orange Barrel Media

We pioneer landmark media and smart city technology to improve lives in cities.

Director158 days ago
OtherRemoteTeam 51-200Since 2004H1B No Sponsor

• Increase the number of large format signs and IKE kiosks throughout the country • Develop relationships with key stakeholders in the markets they oversee • Secure deals with real estate developers and cities

Texas
$70K - $90K / year
Job Closed
OtherRemoteTeam 1,001-5,000H1B Sponsor

• The Managing Director, Strategic Accounts role is a dynamic, fast paced position, serving as the single executive accountable for client health, strategy, success, and growth • Own a book of client specific P&Ls including retention, expansion, and operational efficiency • Foster executive relationships at client accounts • Lead a team of account directors and managers • Act as a strategic advisor and consultative partner • Help identify opportunities for more impactful management of health plan’s specialty care initiatives • Manage the commercial process for these growth opportunities in collaboration with Business Development, Corporate Development and Operations leaders • Develop and orchestrate market-specific and enterprise performance initiatives • Cultivate productive, trusted relationships with key partner executives and stakeholders • Own the strategy and execution of the commercial process for contract management, negotiation, and renewals

California
$160K - $180K / year
Job Closed
OtherRemoteTeam 5,001-10,000H1B Sponsor

• Serve as lead partner and contact for Analytics on portfolio/brand engagement for team and clients • Design and lead presentations and communicate business value derived from each engagement to senior clients • Provide oversight for data analysis and interpretation of results in business context, presenting findings and implications to key stakeholders at all levels • Collaborate with the client team and internal SMEs to improve campaign performance and user experience • Manage scoping and budgeting process for assigned portfolio and brands and maintain relationship with AM/PM to ensure up-to-date analytics scopes • Ensure deliverables are on time, accurate, and compelling to client/business objectives and manage internal teams’ and clients’ expectations regarding timelines

California
$165K - $215K / year
Job Closed
OtherRemoteTeam 5,001-10,000H1B Sponsor

• Consulting with Creative, Account and Planning teams to develop compelling medical content across all digital and print media • Identifying new medical advances and opportunities, and implementing disease state knowledge to drive promotional efforts • Analyzing clinical data, conducting literature searches, participating in medical conferences and performing competitive analyses • Engaging and informing colleagues, healthcare professionals and clients, including medical, legal and regulatory groups • Collaborating in the development of EVERSANA INTOUCH POVs and recommendations with clients • Ensuring medical communications and promotional pieces meet and surpass marketing team objectives • Guide the creation of clinically cogent and engaging promotional and KOL materials while ensuring effective use of clinical data to reach strategic brand objectives • Improve medical literacy across contributing agency teams; provide medical understanding on disease states, clinical trials, treatments and competition • Guide submissions for client medical/regulatory approval processes and help to incorporate client and regulatory feedback • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.

New York
$119K - $170K / year
Job Closed