We provide IT Staff Augmentation Services!

Director Of Clinical Data Management Resume

4.00/5 (Submit Your Rating)

Dickinson, ND

SUMMARY

  • To secure a position which my strong interpersonal skills and professional background will be utilized.

PROFESSIONAL EXPERIENCE

Confidential, Dickinson, ND

Director of Clinical Data Management

Responsibilities:

  • Overseer Data Management, Safety, and Bio stats departments
  • Effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, Standard Operating Procedures and client expectations
  • Create Standard Operating Procedures
  • Create Working Practices and Guidelines
  • CRF Design Database Build/Programming and maintenance
  • Set up DM Department, while displaying my ability to perform as the study and department expert for DM processes
  • Manage and perform study start up activities, study maintenance, and final study activities
  • Manage, co - ordinate, oversee, and deliver all data management related activities for allocated team
  • Manage, coach, and develop members of the DM Team
  • Effectively manage and motivate others
  • Forecast project resourcing and hours needed, prepare budgets for RFPs, and review utilization and make decisions/adjustments as necessary
  • Participate in BID defense Meetings as a major part of the Sr. Management Team
  • Supervise and delegate tasks
  • Ensure the consistent delivery of quality clinical trial data to Sponsors within the specified timeframe
  • Liaison for third party vendors and client
  • Database Management and discrepancy review
  • Perform SAE reconciliation and external data reconciliation (E.g. Labs)
  • Review trial data for divergence from protocol and ensure accuracy of clinical data
  • Demonstrates basic knowledge of safety concepts. Focuses on standards set out in ICH and FDA, sponsor and internal guidelines for drug safety reporting requirement.
  • Write, review and track study summary safety narratives
  • Review and evaluate AE case information to determine required action based on internal policies and procedures
  • Enter safety events and information in centralize safety database and ad hoc databases
  • Assist Medical Monitor in non-clinical review and identification of safety trends
  • Liaison between internal and externals teams regarding the evaluation, communication, and review of safety data
  • QC and review TFLs for consistency and accuracy
  • Conduct and attend teleconferences

Confidential, NJ

Team Manager of Clinical Data Management Operations

Responsibilities:

  • Manage, co-ordinate, oversee and deliver all data management related activities for allocated team
  • Recruit, manage, coach and develop members of Data Management Operations
  • Perform employee performance reviews
  • Ensure the consistent delivery of quality clinical trial data to Sponsors within the specified timeframe and monitor the project budget, resource and implement cost control measures as appropriate
  • Participate in, and support Business Development activities, i.e. bid defense meetings etc.
  • Contribute to preparation and review of documentation to support Sponsor Request For Proposals
  • Actively promote and represent Cmed via attendance at meetings and conferences as appropriate
  • Perform staff appraisals and conduct staff one-to-one meetings for line management staff
  • Assist and act as deputy for Local Head of Data Management Operations as appropriate
  • Contribute to, and implement, process and technical improvement efforts, monitor the outcome and recommend further action
  • Creation of Data Transfer Specifications
  • Liaison for third party vendors and client
  • Timeaus Database Management and discrepancy review
  • Performing serious adverse event and external data reconciliation (e.g. lab data, PFT data, Randomization data), in order that databases can be declared clean and locked according to strict quality standards
  • Reviewed trial data for divergence from protocol and ensure accuracy of clinical data

Confidential, MD

Manager, Clinical Data Management

Responsibilities:

  • Responsible for Data Management activities and processes on Infectious Disease Trials
  • Ensure effective management of assigned projects or functions through accurate and timely communication with appropriate project team members and customers
  • Manage workload allocation and establishing priorities for assigned project teams
  • Ensure the quality, efficiency and timeliness of the work for assigned staff as well as ensure timelines and contracts are adhered to and quality standards are met for assigned projects
  • Oracle Clinical Database management and discrepancy review
  • Prepare material and present at Investigator meetings and Kick-off meetings
  • Identify errors and inconsistencies in CRF data and ensure their resolution
  • Performing serious adverse event and external data reconciliation (e.g. lab data, PFT data, Randomization data), in order that databases can be declared clean and locked according to strict quality standards
  • Reviewed trial data for divergence from protocol and ensure accuracy of clinical data.

Confidential, NJ

Sr. Manager, Clinical Data Management Operations

Responsibilities:

  • Oversee clinical data management operations
  • Manage the resources and workload of direct reports
  • Provides work direction and support to Data Management teams and Clinical Trial Teams
  • Responsible for staffing and performance management
  • Ensure effective management of assigned projects or functions through accurate and timely communication with appropriate project team members and customers
  • Manage workload allocation and establishing priorities for assigned project teams
  • Ensure the quality, efficiency and timeliness of the work for assigned staff as well as ensure timelines and contracts are adhered to and quality standards are met for assigned projects
  • Participate in departmental process developmental initiatives, specifically, SOPs and Working Practices, protocol review and Case Report Form (CRF) design; Data Management Plan development, Data Review Plan development, review and maintenance, data flow description, CRF Inventory Checklist, Data Entry Guidelines, Mock CRF’s, CRF Completion Guidelines, Data Handling Conventions (SEC), Data Validation Specifications (edit checks), SAE Reconciliation
  • Participation in establishing and defining Database Lock and Freeze Checklist
  • Overseer the delivery of weekly Metrics reporting
  • Oracle Clinical Database management and discrepancy review
  • Manage all data management activities from Study Start-up to Database lock
  • Provide timely and professional ongoing management of clinical trial data, Phases I to III, by preparing validation plans and chairing validation meetings
  • Prepare material for and presenting at Investigator meetings and Kick-off meetings, identify errors and inconsistencies in CRF data and ensure their resolution
  • Performing serious adverse event and external data reconciliation (e.g. lab data, PFT data, Randomization data), in order that databases can be declared clean and locked according to strict quality standards.
  • Represent the DM function in International Clinical teams, to define project as well as trial level data management strategy
  • Participate in BID defense meeting to assist with the appropriate selection of vendors
  • Manage Contract Research Organizations and external vendors

Confidential .New York, NY

Clinical Data Manager

Responsibilities:

  • Give Data management Instructions and support all study teams.
  • Extensive (EDC) Electronic Data Capture utilizing Inform PhaseForward systems, Pheonix Data Systems, & Medidata
  • Word Processing/Data entry
  • Create and review edit checks
  • SAE Reconciliation
  • Review protocols and ophthalmic trial data for divergence from protocol and ensure accuracy of clinical data. (Manual review, automated batch review, ophthalmic review and Coding queries)
  • Development of Data Management Plan and Data Review Plan
  • Review Data Validation Plans for all studies
  • Database building, testing, validation and updating
  • CRF Review/Design/Quality Check
  • Query Generation/Query tracking/Discrepancy
  • Case Report Form Design of new protocols and amendments
  • Maintain and audit all data collected
  • Create Case Report Form Guidelines
  • Identify and create monthly abnormal Lab Listings for Drug Safety
  • Create monthly Listing of Number of Treatment given (to date) in study for Drug Safety.
  • Provide patient profiles and listing to Drug Safety as requested
  • Train new Data Management staff on all procedures, processes and applicable systems/databases.
  • Update Data management trackers
  • Create and provide listings for all studies as requested by Clinical
  • Quality Control
  • Adverse Event Coding using MedDRA
  • Con Med Coding using Who Drug
  • Liaison with vendors: Quest, IDDI, PDS and PhaseForward
  • Create SOPs and Best Practice Guidelines

Confidential . Teaneck, NJ

Clinical Data Management-Biometrics/Clinical Data Associate

Responsibilities:

  • Reviewed trial data for divergence from protocol and ensure accuracy of clinical data. Initiated and forwarded data queries to study managers requesting clarification of discrepancies noted during reviews.
  • Reviewed query responses and updated data tables to reflect information received from sites.
  • Responsible for analysis and revision for all record problems encountered by data entry staff during input of information into database.
  • Compiled study information for clinical case report forms forwarded from clinical operations and distributed to data entry staff of Biometrics Department for database entry.
  • Responsible for all incoming data from study sites and establishing a record in database for all study subjects for ongoing clinical trials in Clintrial 4.1 and 4.2 databases.
  • Ensured proper tracking and integrity of incoming clinical data for all study subjects by coordinating and cataloging information in Microsoft Access database.
  • Assigned to all phases on the CNS and GI team performing tasks as assigned by Manager.
  • Major contribution in a filing system for all study files and ancillary documents.
  • Member of Quality Control Team.
  • Generated and resolved discrepancy (differences between 1st and 2nd entry) reports on clinical data.
  • Carry out validation and merging of clean data.
  • Acted as a liaison between Clinical Operations and Biometrics Departments to obtain missing clinical data from case report form books.
  • Responsible for training new employees on systems of tracking, filing, faxing within the Biometrics Department.
  • Assist data entry staff with any problems or questions in regards to clinical data, tracking, filing, etc. Direct data entry staff to appropriate manager for assistance.
  • Created and designed Filing Calendar on a monthly basis to delegate appropriate person(s) for assigned day of filing case report form books and folders for newly enrolled subjects.
  • Data entry and verification of clinical data as needed.
  • Adverse Event and Concomitant Medication Coding
  • Responsible for Ad hoc requests in regards to clinical data.

Confidential, NJ

Certified Nursing Assistant

Responsibilities:

  • Assistant patients with activities of daily living.
  • Responsible for patient personal hygiene care of up to ten patient assignments.
  • Assessed and recorded vital signs
  • Provided unit charge nurse with a detailed report for assigned patients during shifts.
  • Observed and recorded clinical observations on suicidal patients on a one-to-one basis for shift. Reported observations, activities, and changes in patient behavior to oncoming shift.
  • Wound and decubiti care. Dressing changes per physicians’ orders on assigned patients.
  • Ensure patient safety, applying and rotating restraints as ordered.
  • Interacted as a part of health care team to provide input on clinical objectives for patients.
  • Comply with patient and family Bill of Rights.

We'd love your feedback!