Clin Data Mgr I

Covance Dallas , TX 75201

Posted 2 months ago

Job Overview:

Lead Project Data Manager, FSP

permanent, salaried

Remote from anywhere in the U.S. or Canada

Get ahead in your career and make a difference in people's lives!

Are you a self-starter who knows how to take initiative in your daily work? Would you enjoy making a real difference in the lives of others.

If you are looking for a high-energy position in a collaborative environment, learn more about the Lead Data Manager opportunity with Covance.

The Lead PDM leads and/or supports the execution of data management activities necessary for the generation of hypothesis and for decision making in research or development phases, and for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community. May assume the business role of a Study Data Manager in one or more clinical studies. In this capacity, s/he serves as the primary contact for Data Management on the Core Study Team. As an SDM, the Senior Clinical Data Manager leads the DM team, which is comprised of several extended study team members, to ensure data management deliverables meet, or exceed, corporate and industry quality standards in a timely and cost efficient manner. This includes the co-accountability with the Statistics Lead to create, maintain and manage the Project Plan. May also support research-driven activities, or support the handling of data provided by highly specialized functions (e.g., Pharmacokinetic data, Biomarker data) ensuring data management best practices, and the usability of the generated data in regulatory processes.

The Lead PDM may also assume the role of a key driver of medical standards implementation and maintenance at the project level as well as ensuring a consistent standards handling in the project's studies. This critical responsibility is necessary to ensure the project data is aligned with the Clinical Development Plan. Ensures consistency across studies through close interaction with the Clinical Project Team or Early Clinical Team, mentoring/coaching of SDM(s) and overseeing the Data Management team.


  • Serves as the key subject matter expert on topics related to data management activities including specific activities and processes in early clinical development phases. Contributions include, but are not limited to: vendor selection and management, mentoring junior staff, training team members, leading or contributing to expert working groups (e.g., QSD initiatives), presenting best practices at internal and external industry meetings meetings/congresses, and participating in due diligence assessments.

The Lead PDM is responsible for the consistency in support, planning and delivery of data management deliverables in assigned studies, projects (if applicable), or research activities. S/he is contributing to the development and sharing of best DM practices. These efforts cascade throughout the supported research and drug development value chain.


  • Assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and apply Data Management best practices

  • Accountable or a contributor for CDM deliverables from protocol creation until release of data for analysis.

  • Ensure CDM input and contributions to Risk Management (risk identification, risk communication, incorporation of risk in risk management plan, implementation of risk mitigation activities in relevant plans)

  • Incorporates and maintains Medical Standards in clinical studies for all elements of the medical standards package.

  • Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the documentation, maintaining document management systems, coordinating and ensuring contributions from relevant functions, requesting a timely QC of the documentation, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.

  • Specifies and develops study specific eCRFs, data consistency checks based on Medical Standards, the Clinical Study Protocol and input from the study team.

  • Prepares, tracks and implements standard plans (i.e., Project Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities.

  • Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of important deviations and validity findings, planning and conduct of interim and final Blind Review Meeting, preparation and completion of the final Blind Review Report.

Engages actively in ongoing data review/reconciliation activities and utilizes dashboards, metrics and patient trackers to

monitor data arrival and clean up. Shares data arrival and cleanup status and metrics with the Study Team

  • As applicable, plans and tracks data contributions of specialized functions typically used for early clinical development activities like Pharmacokinetics, Biomarker, Bioinformatics, Pharmacometrics, as well as strategic operational partners.

  • As applicable, establishes data management best practices for data generated in relevant research activities which may be needed in later project activities like decision making processes and submissions. This includes but is not limited to the following: support of setting data standards compatible with development standards, support of central storage and inventory, supporting data transfer activities from external vendors, supporting integration with data generated in clinical phases of development.


  • Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.

  • Identifies and issue queries, incorporate query replies and track query status.

Implementing Strategy

  • Contributes to projects and initiatives aimed at improving and optimizing the delivery of DMAR, DS&A, Portfolio & Operations, OSBU.

Ensuring Compliance

  • Performs duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.

  • Ensures complete, accurate and timely documentation for all projects/studies according to established SOPs.


  • Represents CDM as the Core Study Team member for internal and outsourced studies, and coordinates the DM Team in any aspect.

  • Tracks and leads project-level data management activities: manage PDM Teams/Early PDM Teams efficiently; ensures the timely delivery of high-quality study databases and smooth operation of SDM teams; identifies issues, defines and directs resolution measures; reports progress and escalate issues into management.

  • Manages cross-functional team memberships and interfaces effectively: closely aligns activities with Statistics function applying the 2-Lead model principles, serves as CDM member of the core Clinical Team or Early Clinical Team (as applicable).

  • Works closely with clinical and safety experts in the definition, preparation and review of reports that are critical to ensuring the quality, accuracy and completeness of analyses on study safety, medical coding and Pharmacovigilance data.

  • Establishes and tracks data management activities in co-operation with Pharmacokinetic department and Pharmacometrics department, with internal research functions like Biomarker and Bioinformatics, and with strategic external partners.

  • Develops robust and productive relationships with internal and external business partners: treats others fairly and with respect; manages conflicts constructively; provides timely and relevant feedback.

Thrive personally and professionally as a Lead Project Data Manager

Working at Covance, you can bring your skills to the team and expect comprehensive training so that you can continue to grow in your career. You will serve as the technical leader on all projects and identify and implement solutions for our clients in data management.

We also offer a competitive benefits package that takes care of you. This includes medical and dental insurance as well as tuition reimbursement, a 401(k) plan with a generous company match, PTO days along with short and long-term disability and life insurance.

Why choose to work at Covance

  • Make a direct impact in the lives of patients

  • Become successful in the position with exceptional training

  • Join a high-energy and team-driven workplace

  • Open up new opportunities for career growth

What we're looking for

Lead Data Managers are the most successful at Covance with:

  • 6+ years of Clinical Data Management experience and at least 5 years of leading studies in a CRO setting. Combination of CRO/Pharma is acceptable.

  • Bachelor's degree; additional relevant work experience considered in lieu of degree.

  • Full Experience including study start up, initiation, close out etc.

  • Demonstrated skill for technical management of studies with 5+ staff.

  • Experience with Database Build; eCRF creation; UAT experience.

  • Demonstrated mentoring/delegation, communication and interpersonal skills

Get to know Covance

At Covance, we value your unique point of view and bold ideas to advance modern healthcare. Join our team and see how our collaborative work environment along with mentoring, training and career development can help you be successful at work and in your personal life.

Together, let's shape new possibilities for your career and advance healthcare around the world.

Covance is an equal opportunity employer and will not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.


  • University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

  • Additional relevant work experience will be considered in lieu of formal qualifications.

  • Broad knowledge of drug development processes.

  • Understanding of global clinical development budgets and relationship to productivity targets.

  • Knowledge of effective clinical data management practices.

  • Knowledge of time and cost estimate development and pricing strategies.

  • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, especially as related to data handling and processing.


  • Minimum five (5) years relevant work experience in clinical data management and 5 years of clinical data lead experience in Pharma and or CRO setting

  • Minimum of 3 years of onoclogy experience required.

  • Financial management of gross revenues

  • Excellent oral and written communication and presentation skills.

  • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.

  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies.

  • Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.

  • Demonstrated managerial and interpersonal skills

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Data Warehouse Manager A Big Data & AWS Lovers Dream Job

Camden Kelly Corporation

Posted 3 days ago

VIEW JOBS 11/25/2020 10:55:00 PM 2021-02-23T22:55 With a couple of billion dollars in startup investments fueling them, it’s no wonder this innovative company is rocketing towards success so quickly! Be a part of their exciting journey as you oversee the design, implementation, maintenance, and support of a brand new data warehouse system and improve your work-life balance with flextime in this <strong>Data Warehouse Manager </strong>position. <br /> <br /> Even though this company is set to double in size before the year is over, they’re determined to retain their family-like feel. With a great board of directors and a very family-oriented culture that will make you feel right at home, you'll be fully supported as you come in and start from scratch establishing a warehouse. In order to succeed, you’ll need to be confident in your experience with ETL tools (Matillion, Tableau, Snowflake) AWS, and various audit tools. Yes, you'll also need management experience - but only 50% of the time. From typical project management activities to overseeing all data analysis, you will stay busy - but you'll be able to use the Data warehouse as a full interface hub! Doesn't get any cooler than that! <br /> <br /> <strong>The easiest part of this job:</strong> This awesome team collaborates and works alongside each other really well and they’re so close-knit they’ll feel like your second family - plus you'll earn great perks like flextime when you work here. <br /> <br /> <strong>The hardest part of this job:</strong> If you cannot collaborate effectively with other developers to complete complex tasks and move projects forward, this won’t be the right job for you. <br /> <br /> Establish and lead an effective data warehouse and have a long tenure at a family-like company you’ll love working for in this <strong>Data Warehouse Manager </strong>role. Apply today! <br /> <br /> <strong>What’s in it for you? </strong><br /> - Competitive Salary ($130,000-$150,000) <br /> - Medical <br /> - Dental <br /> - Optical <br /> - 401k with 50% Match up to 6% <br /> - Flextime <br /> - 20 Days PTO <br /> - Paid Holidays <br /> <br /> <strong>What you’ll be doing: </strong><br /> - Own the design, implementation, and maintenance of the data warehouse system <br /> - Create, deploy, and manage the data architecture and data design <br /> - Collaborate with Project Managers, Developers, and Production support to ensure goals are met <br /> - Oversee all data analysis and install processes for auditing transfers, storage, and data quality <br /> - Determine the company’s data needs and create a systems design to accommodate them <br /> - Implement standards and best practices for data architecture and make sure developers are compliant with those standards <br /> <br /> <strong>What you need: </strong><br /> - ETL <br /> - Matillion <br /> - Tableau <br /> - Snowflake <br /> <br /> - - - - -- - - - - - - - - - <br /> <br /> <br /> <strong>About Camden Kelly </strong><br /> <br /> Camden Kelly specializes in connecting qualified IT professionals with awesome opportunities at great companies in the Dallas / Fort Worth Area. Whether you’re a jobseeker looking for new opportunities or an employer looking to hire the best IT talent in the area, Camden Kelly is your go-to IT recruiting firm. Why work with us? It’s simple; our staff is filled with career oriented people just like you, and they will treat you how they expect to be treated. <br /> <br /> At Camden Kelly, our values make us different than the competition. We are the proud recipients of the Best and Brightest award for 2016 and 2017. We believe in being honest, accountable, ethical, and reliable. We strive everyday to be better than we were yesterday, and to be better tomorrow than today. We’re not competing against other firms; we’re competing against ourselves. <br /> <br /> Visit <a href="" target="_blank"></a> to explore opportunities in your area, and while you’re at it follow us on Twitter (<a href="" target="_blank"></a> and Linkedin (<a href="," target="_blank">,</a> fan us on Facebook (<a href="" target="_blank"></a> and join our circle on Google+ (<a href="" target="_blank"></a> to stay up-to-date with current jobs, industry news and job hunting resources. Also feel free to contact us directly at <a href=""></a> or 972-643-8848. Camden Kelly Corporation Dallas TX

Clin Data Mgr I