Joseph Matassini

**** ****** ****., ********,******* L9S 2A9 705-***-****

EXPERIENCE

Senior Clinical Data Manager – June 2008 to Present

Reporting to Manager, Clinical Data Management, i3 Statprobe

Responsibilities:

Assumes overall responsibility for the successful execution of the data management projects.

Writes, reviews and approves all required trial data management documentation.List current duties in present tense.

Performs any data management activities related to projects, as needed.

Provides leadership and may supervise Data Management staff assigned to work on their projects, including Clinical Data Coordinators and other Data Mangers.

Monitors the progress of all data management activities for the project to ensure that project timelines are met.

Monitors the quality and coordinates all data management QC activities for the project.

Monitors the data management process for the project to ensure that work is proceeding in an efficient manner.

Serves as Data Management contact with sponsor managing their expectations, noting and responding to out-of-scope work.

Some business development work may be required, such as input to proposals and client presentations.

Remain informed of new developments in data management that are relevant to the industry.

Participate in the development of Standard Operating Procedures (SOPs) and guidelines.

Provide feedback to team members and supervisors (if applicable) on individual performance and contributions to the overall team effort in a constructive manner.

Some line management activities may be required.

Work effectively with international peers and sponsors, as needed.

Have thorough understanding of data management budgets and can communicate out of scope requests to the project manager.

Accomplishments:

Phase I

Oncology (Dose Escalation) – multicentre trial

Oncology (Advanced Cancer) – multicentre trial

Phase lb

Oncology (Ovarian Cancer) – multicentre trial

Phase III

Oncology (Lung Cancer) – multicentre trial

Phase IV

Dry Eye – multicentre trial

Sickle Cell Disease – multicentre trial

Type II Diabietes – multicentre trial

Lead Clinical Data Associate – March 2008 to June 2008

Reporting to Manager, Clinical Data Associates, Clinimetrics Research

Responsibilities:

Coordinate receipt and processing of electronic data received from specialty groups utilized on projects (e.g. data from central laboratories).

Establish/negotiate CDM timelines and ensure CDM project milestones are met.

Responsible for the development of standard and custom database status reports to meet the needs of Clinimetrics project team members and Sponsor expectations.

Recognize data management project issues needing to be brought to the attention of the Sponsor or other Clinimetrics functional. Also responsible for communicating other project issues that may be recognized as having an impact on any other services being provided to the appropriate Clinimetrics project team member.

Direct the activities of other CDM personnel on assigned projects to ensure timely completion of high quality projects.

Responsible for ensuring clinical databases are validated and ready for transfer and/or analyses (database “freeze” and “lock”).

Provide input for departmental budget and staffing projections and recruiting efforts.

Coordinate paper and electronic archiving process for completed projects.

Provide input for job performance reviews for CDM employees.

Performs other tasks required within Clinical Data Management as necessary to meet the needs of the business.

Accomplishments:

Phase IV

Psoriatic Arthritis– multicentre trial

Psoriasis– multicentre trial

Clinical Data Project Manager – August 2006 to March 2008

Reporting to Director, Clinical Data Management, Endpoint Research

Responsibilities:

Provide project management for Endpoint projects involving data management services.

Serve as the primary Endpoint CDM contact with Sponsors.

Represent CDM on Endpoint project teams.

Coordinate receipt and processing of electronic data received from specialty groups utilized on projects (e.g. data from central laboratories).

Coordinate the receipt and implementation of Sponsor’s coding dictionaries, format libraries, and transfer database specifications.

Establish/negotiate CDM timelines and ensure CDM project milestones are met.

Directs the building and validation of Endpoint clinical databases.

Responsible for the development of standard and custom database status reports to meet the needs of Endpoint project team members and Sponsor expectations.

Recognize data management project issues needing to be brought to the attention of the Sponsor or other Endpoint functional. Also responsible for communicating other project issues that may be recognized as having an impact on any other Endpoint’s services being provided to the appropriate Endpoint project team member.

Direct the activities of other CDM personnel on assigned projects to ensure timely completion of high quality projects.

Develop and maintain CDM project specific Working Guidelines.

Responsible for ensuring clinical databases are validated and ready for transfer and/or analyses (database “freeze” and “lock”).

Provide input for departmental budget and staffing projections and recruiting efforts.

Coordinate paper and electronic archiving process for completed projects.

Provide input for job performance reviews for CDM employees.

Performs other tasks required within Clinical Data Management as necessary to meet the needs of the business.

Accomplishments:

Phase I

Dermatology (Hair Loss) – 1 multicentre trial

Allergy (Seasonal Rhinoconjunctivitis) – 1 single centre trial

Oncology (Advanced Refractory Neoplasms) – 1 multicentre trial

Congenital Hemophilia (Bleeding Disorder) – 1 multicentre trial

Cystic Fibrosis – 1 multicentre trial

Oncology (Prostate Cancer) – 1 multicentre trial

Oncology (Carcinoma) – 1 multicentre trial

Oncology (Multiple Myeloma) – 1 multicentre trial

Phase II

Oncology (Acute Myelogenous leukemia/high risk MDS) – 1 multicentre trial

Lymphocytic leukemia – 1 multicentre trial

Respiratory (Asthma) – 1 multicentre trial

Cardiac Arrhythmia (Atrial fibrillation) – 1 multicentre trial

Phase IIb

Oncology (Prostate Cancer) – 1 multicentre trial

Phase III

Cystic Fibrosis – 1 multicentre trial

Clinical Data Manager – March 2004 to August 2006

Reported to Manager, Clinical Data Management, Everest Clinical Research Services, Thornhill, ON

Responsibilities:

Managed and maintained a variety of data used in support of analytical and/or research projects ensuring consistency and integrity of data.

Oversaw collection and reporting of complex, related information.

Accomplishments:

Phase II

Osteoarthritis – 1 multicentre trial

Phase II – Oncology (Breast Cancer) – 1 multicentre trial

Provided assistance and training to system users.

Developed and designed methods and procedures (SOPs, DMPs) for collecting, organizing, interpreting, and classifying information for input into computer and retrieval from computer.

Clinical Data Management Specialist - February 2003 to December 2003

Reported to Manager, Clinical Data Management, Pfizer (Pharmacia) Markham, ON

Responsibilities:

Specified database integrity checks.

Defined and monitored clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and departmental guidelines.

Liaised and coordinated with site monitors and site coordinators to resolve data issues.

Validated trial data capture by electronic data capture tools or entered by DataFax lower level data validation personnel.

Performed quality control procedures on assigned database during the trial, and additional database closure checks at the end of the study.

Validated and distributed study monitoring reports to the study team members.

Assisted in resolving data coding discrepancies resulting from the coding of medical events, procedures, and medications.

Accomplishments:

Phase II

Breast Cancer - 1 multicentre trial

Osteoarthritis - 1 multicentre trial

Data Coordinator/Global Case Report Form Designer – January 1994 to December 2002

Reported to Manager, Clinical Data Management, Aventis Pasteur, Toronto, ON

Responsibilities:

Designed all International Case Report Forms. Created as well as maintained all Gantt charts within Clinical Data Management to ensure all project timelines were kept.

Coordinated all data received, which was then validated.

Prepared all data for double data entry.

Reviewed all output which was received from data that had been double entered against CRF in preparation for data lock.

Issued queries to sites upon receipt of discrepancies within data.

Provided training as well as support for data management and clinical and medical personnel.

Took part in the launch of Clintrial software, which consisted of database set-up and numerous system validation checks.

Accomplishments:

Phase I

Oncology (Melanoma) – 1 single center trial

Phase I –II

Respiratory Syncytial Virus - 1 multicentre trial

Phase I-IV

Pertussis - 1 multicentre trial

COMPUTER PROFICIENCY

Electronic Data Capture

Clinical Analytics

PDS Express

PRISM

InForm

I-Review

Oracle Clinical

Oracle Clinical RDC

Clintrial

DataFax

Microsoft Office

Microsoft Project

Jet Form Design

Microsoft XP

Microsoft NT

CERTIFICATIONS

Microsoft Project, current

Basic SAS Knowledge & Manipulating Data Using a Data Step, current

Clintrial, current

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