Associate Clinical Data Manager

Covance Philadelphia , PA 19107

Posted 3 months ago

Job Overview:

Associate Clinical Data Manager, FSP

permanent, salaried

Remote from anywhere in the U.S. or Canada

SUMMARY

  • Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets.

  • Potential to assist in the development of the project Data Management Plan, including the creation of data acquisition conventions and data review guidelines / diagnostics specification; and set-up of the data management systems according to project requirements.

  • Potential to serve as the technical data management leader on small projects with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.

DUTIES

  • Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.

  • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.

  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.

  • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application.

  • Perform reconciliation of the clinical and safety databases.

  • Perform reconciliation of central laboratory and / or third party vendor data (eCRF, edDiary, specialty laboratory, etc.).

  • Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.

  • Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved.

  • Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc.

  • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.

  • Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.

  • Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCFR) completion / monitoring conventions.

  • Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.

  • Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.

  • Potentially serve as client contact for project meetings and CDM status updates.

  • Support the training of project staff on project-specific, global, standardized data management processes.

  • Perform other duties as assigned by management.

Education/Qualifications:

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).

  • In lieu of the above requirement, approximately 18 months experience in related field (e.g. pharmaceutical, laboratory, data analysis) incorporating approximately one year's clinical data management experience in addition to the 4 years relevant work experience in data management will be considered.

  • Knowledge of drug development process.

  • Knowledge of effective clinical data management practices.

  • Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.

  • Fluent in English, both written and verbal.

Experience:

Minimum 4 years relevant work experience with increasing responsibility in data management with knowledge of 2 or more therapeutic areas.

  • Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.

  • Potential ability to lead by example data management staff.

  • Demonstrated ability to work in a team environment and collaborate with peers.

  • Demonstrated interpersonal skills.

  • Excellent oral and written communication skills.

  • Ability to demonstrate a constructive problem-solving attitude while dealing with time demands, incomplete information or unexpected events.

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
lc_ad

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
Associate Clinical Data Manager

Ockham

Posted 3 weeks ago

VIEW JOBS 10/31/2021 12:00:00 AM 2022-01-29T00:00 Job Overview: Associate Clinical Data Manager-Remote * Collaborate and functionally report to Lead DM (LDM) for studies which include but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements. * As a lead data reviewer and support to the lead Data Manager, you will perform all data operational tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and Sponsor) are achieved. * Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, Labcorp global harmonized SOPs or client SOPs, and the specified standards of GCPs. * Work with the LDM to build study milestone timelines and demonstrates capability to read and follow study timelines for on-time deliverables. And capable and knowledgeable on study design to make suggestions to study timelines when warranted. * Assist or lead the internal and external Data Management meeting * Assist or lead to write, update/review and approve all required trial data management documentation; including, but not limited to: Study-specific case report forms o CRF Completion Guidelines o Data Management Plan o Data Quality Checks (edit checks) * Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts). * Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study. * Track scope changes and work with the Lead DM to ensure that Sponsor approval is received, and the scope change processed. * Supports the training of new staff on project specific Data Management processes. Ensures service and quality meet agreed upon specifications per the DMP and scope of work. * Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate. * Coordinate with DM study team to ensure the receipt and inventory of all data related information is delivered within agreed upon timelines. * Ensure all appropriate documentation and procedures are performed upon project completion for operations team. * Assist or lead the managing of the DM study team ensure client satisfaction is achieved through delivery of quality data. * Assist or coordinate the internal or external meetings as appropriate. * Attend client or internal audits as appropriate and resolve all issues within an appropriate timeframe. * Address client comments with the study team. * Assist or provide reports to Sponsor and internal team as dictated by project need. * Assist or lead with the completion of Database Lock and Unlock activities with LDM. * Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required. * Performs other related duties as assigned by Line Management #LIREMOTE Education/Qualifications: * University / college degree (life sciences, health sciences, information technology or related subjects preferred). * Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree. * Fluent in English, both written and verbal. Experience: * 6 to 8 years of DM experience. * Experience in handling customer concerns and experience with managing Scope of Work and budgets is preferred. * Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations. * Time management skill and ability to adhere to project productivity metrics and timelines. * Ability to work in a team environment and collaborate with peers. * Good organizational ability, communication, and interpersonal skills. * Team working skills and good collaborator skills. * Knowledge of medical terminology. * Knowledge of science or a scientific background is preferred Ockham Philadelphia PA

Associate Clinical Data Manager

Covance