Hector Robertson
Brooklyn,NY
Summary
Experienced working within Pharma Companies, Biotech, Radiopharmaceutical Oncology diagnostic, Contract Research Organizations (CROs) and Diagnostics companies. Accountable to managing highly complex clinical data management projects and responsible for clinical data management tasks to collect, code, process, review, and validate clinical trial data. Manage internal projects teams as well as vendors project teams, budgets, and timelines for all studies and for all data and activities performed ensuring high quality data in support of publications and regulatory submissions.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Assoc. Director, Clinical Data Management
Lantheus Medical Imaging
04.2018 - Current
- Responsible for the management of 4 data managers direct reports
- Report to the Vice President, Biometrics and Data Management
- Lead the clinical data management team and processes across Lantheus clinical trials
- Responsible for the development of clinical trial planning through data generation and database lock
- Lead the clinical data management process flow by following best practices as well the oversight of data management vendors, data transfers and data handling
- Manage the clinical data management partnership portion of the study with external vendor for Lantheus clinical trials, establish and maintain relationships with those vendors, ensuring effective communication and collaboration to meet project timelines and deliverables
- Provide oversight for fully outsourced clinical data management activities from RFP to final database lock and data Quality Check by working effectively with CRO partners by collaborating in the development and standardization of data handling plans, data transfer specifications, metrics, and data review tools
- Approve final database design and entry screens, edit checks, eCRF completion guideline, and Data Management Plan for all data management studies and ensure the appropriate CDASH and SDTM standards are applied
- Work with cross functional Lantheus team members to standardize data collection and reporting
- Collaborate with cross-functional teams, including Clinical Development Operations, Clinical Development, Biostatistics, Pharmacovigilance, and Regulatory Affairs, to ensure the integration and accuracy of clinical data
- Attend study team meetings to provide updates and issue resolution in terms of data collection through analysis
- Participated in the review of clinical data analysis of tables/listings/figures and patient profiles for data consistency and accuracy
- This will include reviewing and resolving all discrepancies
- Mentor and support data management professionals, providing guidance, training, and performance evaluations to ensure the highest level of productivity and quality
- Additional duties and responsibilities as required
- Led teams of up to [Number] personnel, supervising daily performance as well as training and improvement plans.
- Assisted senior leadership in managing all aspects of operations.
- Fostered a culture of continuous improvement by encouraging staff to share innovative ideas and providing resources for professional development.
- Trained and developed department leaders and management staff for specific projects and ongoing operational needs.
Manager, Data Management
Siemens Healthcare Diagnostics, Inc.
05.2014 - 04.2019
- Oversaw data management activities across multiple studies from study start-up through study closure in support of clinical trial objectives and corporate goals
- Ensured complete, accurate, high quality clinical data for all internal trials were delivered on time and within budget
- Responsible for the development and maintenance of all CDM related SOPs
- Oversaw clinical data management activities across multiple studies
- Prioritized projects and coordinated data management activities in support of corporate goals and objectives
- Participated in the RFP process including the evaluation of potential vendors
- Oversaw the design of the eCRFs and ensured that they conform to Principia's standards
- Responsible for ensuring complete and accurate CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements and data management plans
- Report query trends and data/query metrics and suggest any changes, additional training as appropriate
- Responsible for ensuring data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, Tables, Figures and Listings (TFL), etc
- That are generated for CSRs, DSURs, IBs and other business needs
- Responsible for ensuring all reviews have been completed, including data Quality Check and all documentation has been finalized and approved for final database locks
- Ensure that all data management documentation has been collected and uploaded to the relevant sections of the working files on the server and the study TMF
- Responsible for departmental compliance with regulatory and ICH guidelines, GCPs, company guidelines and Standard Operating Procedures, and CDM best practices
- Address the business needs of CDM functional customers
- Serve as the data management representative on projects and communicate the status of data timelines, changes, issues and risks to the project team and leadership
- Assist with strategic planning activities for the CDM department and participate in the implementation of new departmental initiatives
- Managed the Data Management resources, including recruiting and training high performing data management staff to ensure quality clinical trial execution
- Manage the career development plans for direct reports, performance reviews and building team
Sr. Manager, Data Management
Clinical RM, Inc. (ICON)
09.2009 - 05.2014
- Directed Data Management activities for Phase I-IV studies and ensured that product and study level deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements
- Responsible for the management of salaried and contract CDMs
- Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
- Translate protocols into eCRF and eSource specifications
- Write UAT test scripts (if necessary) for eCRF and eSource forms
- Perform/execute or coordinate User Acceptance Testing (UAT)
- Track database set-up, testing, maintenance, and data entry metrics
- Communicate with internal project teams and vendors on data management matters
- Design and develop project specific guidelines and instructions (i.e., Data Management plan (PMP)) and other project-specific guidelines and instructions
- Development of eCRF completion guidelines
- Develop Data Validation Plan/Edit Check Specifications
- Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
- Design eCRF, Data Management and Data Validation Plans and test EDC databases
- Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
- Ensure data entry, follow-up, and validation, including manual eCRF review and SAE reconciliation
- Track and report metrics leading to database lock
- Perform all database lock activities including data Quality Checks
- Coordinate the processing, dispatch and archiving of CRFs/queries
- Maintain Clinical Data Management working files
- Perform database QC checks, prepare, and attend audits
- Train internal project teams on eCRF completion and data management topics
- Serve as an SME for clinical data management activities
- Provided mentoring, and/or training to data management staff and perform yearly performance evaluations
Data Project Manager
Pharm-Olam, International
07.2006 - 09.2009
- As the Senior Clinical Data Manager, I was responsible for supporting all assigned clinical studies by following company Standard Operating Procedures (SOP) and Guidelines
- Worked as the lead clinical data manager for clinical trials and works closely with the lead biostatistician to develop the data management plan and electronic Case Report Forms (eCRF), build the Electronic Data Caption (EDC) system, author and program the Edit Check specifications, lead and guide the UAT of the EDC system
- Lead data review, generate and solve data queries, create operational data sets, reconcile external data sets and safety data sets, perform database lock activities
- Participate in planning and support of clinical studies
- Implement CDISC/CDASH standards in CDM
- Prepare eCRFs and lead the team review of the forms ensuring compliance with company standards
- Build or participate in the EDC building
- Develop programs and manages the edit check specifications and their implementation
- Perform or oversee and document EDC user acceptance testing
- Facilitate and document review of clinical data by other functional groups
- Reconcile external data (SAE, IVRS, ECGs etc.) and safety database with clinical database using SAS
- Raise manual queries that result for data review and reconciliation activities
- Resolve system and manual queries and perform database lock
- Perform other duties as necessary as assigned by management
Sr. Clinical Data Manager (Contract)
Forest Research Institute
09.2005 - 07.2006
- As the Lead Clinical Data Manager (CDM), my responsibilities included the execution of data management activities necessary for the support of all assigned clinical studies by following company Standard Operating Procedures (SOP) and Guidelines
- Responsibilities also included being the primary contact for all data management concerns and deliverables for the study team
- Serve as The Lead on topics related to Clinical Data Management activities in a multifunctional team
- Managed all assigned studies from study start-up, conduct and database lock
- Including data Quality Check
- Accountable for CDM deliverables from protocol review to database closure and oversee production of SDTM datasets
- Responsible for the review of the clinical protocols and the development of the electronic case report forms and developing the associated edit check specifications
- Responsible for contributing to vendor selection and management, assume operational and/or oversight responsibility as Lead Clinical Data Manager for outsourced studies
- Responsible for the review and approval of specifications or Data Transfer Agreements with external vendors
- Coordinate data transfer activities from external vendors
- Performed duties in compliance with department SOPs and Good Clinical Practices (GCP) set by ICH
- Good project management skills and the use of PM tools (e.g., MS Project)
- Responsible for prioritizing tasks, identifying, and mitigate risks concerning timelines and Data Quality
- Created reports from raw dataset using reporting tools such as MS excel, J-review, and SAS
- Responsible for ongoing data review/reconciliation activities or spot check vendors' and utilize reports, metrics, and patient trackers to monitor data quality
- Developed or reviewed plans associated with the CDM function (i.e., Project Plan/Timelines, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management activities
- Resolve system and manual queries and perform database lock activities (develop database lock check list, database count down schedule, PI final signature instructions document, etc.)
Sr. Clinical Data Manager
Mankind Corporation, Inc.
08.2002 - 07.2005
- Worked closely with Biostatistics, Clinical and Medical Research groups in all aspects of overseeing the CRO DM OR performing all in-house data management including setting up, managing, and completing trials within timelines with the primary goal of ensuring data integrity
- Supported or Managed multiple studies in-house or supervising CROs (May operate as the Trial Data Lead (TDL) depending on study needs)
- Designed eCRF and write eCRF Completion Instructions
- Developed data management plans, edit check specifications, and data review plans
- Conducted User Acceptance Testing (UAT) activities
- Performed SAE reconciliation with the Safety database
- Wrote/resolved and tracked study queries and provided status to study team
- Conducted review of clinical trial data and performed all tasks required for database lock
- Including data Quality Check
- Ensured all study documentation were filed in study electronic files
- Responded and provided trial related support to cross functional groups such as Stats, Clinical Operations, etc
- Provided input in the study timelines, vendor selection, and CRO management and oversight
Sr. Clinical Data Manager
Millenix, Inc.
07.2000 - 06.2002
- Worked closely with Biostatistics, Clinical and Medical Research groups in all aspects of overseeing the CRO DM OR performing all in-house data management including setting up, managing, and completing trials within timelines with the primary goal of ensuring data integrity
- Supported or Managed multiple studies
- Designed eCRF and write eCRF Completion Instructions
- Developed data management plan (DMP), edit check specifications, and data review plans
- Conduct User Acceptance Testing (UAT) activities
- Performed SAE reconciliation with the Safety database
- Wrote/resolved and tracked study queries and provided status to study team
- Conduct review of clinical trial data and perform all tasks required for database lock
- Including data Quality Check
- Respond and provide trial related support to cross functional groups such as s, Clinical Research, etc
- Ensured all study documentation were filed in study electronic files
- Provide input in the study timelines, vendor selection, and CRO management and oversight
Sr. Clinical Data Manager
Ingenix Pharmaceutical Services
09.1998 - 06.2000
- Work closely with Biostatistics, Clinical and Medical Research groups in all aspects of overseeing the CRO DM OR performing all in-house data management including setting up, managing, and completing trials within timelines with the primary goal of ensuring data integrity
- Guided all data management tasks for all in-house and outsourced studies from study start including data verification, database audit, and database lock
- Guided all data management study activities in conjunction with the Clinical Affairs and Biostatistics teams on case report form design, data collection processes, query generation procedures
- Develop Data Management Plan (DMP)
- Managed all phases of CRO data management related activities from study start up to study close out
- Including data Quality Check
- Conducted data quality review
- Conducted data reconciliation with external lab
- Coordinated all SAE reconciliation
- Ensured all study documentation were filed in study electronic files
- Coordinated External data reconciliation (ECG, Labs, IVRS, etc.)
Data Project Manager
Roche Laboratories Inc.
11.1994 - 08.1998
- Work closely with Biostatistics, Clinical and Medical Research groups in all aspects of overseeing the CRO DM OR performing all in-house data management including setting up, managing, and completing trials within timelines with the primary goal of ensuring data integrity
- Managed all phases of CRO data management related activities and deliverables associated with all US and global studies from study start up to database lock
- Developed a Data Quality Management Plan for all studies
- Review and contribute to the development of data base design, validation procedures and documentation for assigned protocol
- Review lab reports/safety listings for coding errors
- Performed data clean-up process adhering to departmental SOP's, procedures before the database can be declared clean and ready to lock
- Including data Quality Check
- Ensured all study documentation were filed in study electronic files
- Coordinated all coding of safety data
Education
BS Biochemistry - Biochemistry
University of Panama
Panama City, Panama02-1978
Skills
- Direct report management
- Understanding of drug development process and regulatory guidelines
- Knowledge of clinical data management processes and requirements
- Experience in building and guiding organizational teams
- Proactive problem-solving abilities
- Strong communication and presentation skills
- Ability to establish and maintain positive relationships
- Excellent time management skills
- Knowledge of 21CFR Part 11 and regulated systems
- Experience leading multiple studies from start-up to data database lock
- Experience leading global clinical trials data management
- Experience with Rave and other EDC systems
- Experience writing department SOPs and work instructions
- Mentor direct reports
- Oracle Clinical/RDC
- Experience with SAP Document and Quality Management Systems
- CFR Part 11 compliance
- Proficient with the use of SAS
- Strong Knowledge of CDISC, CDASH, SDTM and ADaM datasets standards
- Microsoft Products
- Experience with MedDRA and WHODRUG Dictionaries
- Medidata Rave Study Builder
- Inform
- JReview
- JMP Statistical Discovery Platform
- Discoverer
- Normlab2
- Structured Query Language (SQL)
- Proven success in management of data managers or CROs
- Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
- Good Project management skills
- Use of PM tools (eg, MS Project)
Certification
- ICD-9, ICD-10, HCPCS and CPT Medical Coding, Hunter College
- ICH/GCP Certification
- ISO Certification
- Understanding FDA Drug and Biologic AE Regulations
- Paralegal Studies Adelphi University
- ECG Basics
- Oracle DBA
Membershipandaffiliations
- Toastmasters International
- Society for Clinical Data Management (SCDM)
Projectmanagement
Good Project management skills and the use of PM tools (e.g., MS Project)
Therapeuticexperience
- Cardiology/Vascular Diseases
- Dermatology
- Transplant
- Infectious Diseases
- Psychiatry
- Gastroenterology
- Rheumatology
- Urology
- Endocrinology
- Healthy Volunteers
- Sleep
- CNS
- Vaccines
- Oncology and Radiopharmaceutical Oncology diagnostics
Accomplishments
Build and retrained a data management group at Siemens which included updated SOPs, re-developed the data management platform and re-trained all data managers in the use of the new data management system.
Languages
Spanish
Professional Working
Timeline
Assoc. Director, Clinical Data Management
Lantheus Medical Imaging
04.2018 - Current
Manager, Data Management
Siemens Healthcare Diagnostics, Inc.
05.2014 - 04.2019
Sr. Manager, Data Management
Clinical RM, Inc. (ICON)
09.2009 - 05.2014
Data Project Manager
Pharm-Olam, International
07.2006 - 09.2009
Sr. Clinical Data Manager (Contract)
Forest Research Institute
09.2005 - 07.2006
Sr. Clinical Data Manager
Mankind Corporation, Inc.
08.2002 - 07.2005
Sr. Clinical Data Manager
Millenix, Inc.
07.2000 - 06.2002
Sr. Clinical Data Manager
Ingenix Pharmaceutical Services
09.1998 - 06.2000
Data Project Manager
Roche Laboratories Inc.
11.1994 - 08.1998
BS Biochemistry - Biochemistry
University of Panama
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