SUMMARY

Manager of Data Management with experience in all phases of clinical trials. Managed teams in a variety of trials ranging from phase 1 to 4 clinical trials. Successfully, completed several system implementations in SharePoint, EDC, and pharmaceutical manufacturing applications. Created the reporting metrics and dashboards. Supervised and wrote documentation from DMPs, SOPs, protocols, work instructions and training materials for various levels. Delivered professional presentations at global meetings and to smaller audiences. Represented or oversaw the data management department for FDA and internal audits for sponsors and CRO’s. Managed and approved Data Management budget contracts and personnel additions. Managed projects from beginning to end.

PROFESSIONAL EXPERIENCE

Covance, Inc.

Oversight Manager for the Client Program (CRO/Perm) May 2016 – Nov 2017

(Diabetes Trials)

Successfully set up the program for a set of nine Diabetes Trials. Managed the budget, program level metrics, change orders and all program related items. Led the program through several workforce reductions.

Oversight Contributions for the Program

Successfully evaluated the supply vs the demand of staff members for the upcoming months and program development. Resourced and provided training to staff members as each trial was developed. Managed the team through several layoffs. New outsourced teams were brought on board and trained to achieve the new business model.

Negotiated with the client to developed program level metrics and reduced the metrics needed for the staff to provide.

Developed the program budget with finance through several revisions

Held weekly project staff meetings to discuss status, issues and resolutions

Represented Covance for all program level status meetings and escalation of issues

Line Staff Manager other than the Diabetes Program

Provided mentoring and feedback for various line staff members who were assigned to other programs. This included biyearly assessments, awards, feedback, promotion recommendations.

This also included stepping in when some staff was on vacation or out for whatever reason.

Process Improvements

Developed several presentations and championed various topics:

oBudget

oEDC build process and timelines

oStaff efficiency recommendations

oMatching up budget with demand when the resources where needed to accomplish the project

oSuggested a more robust project planning tool than Microsoft Project. This will give real time information and is not reliant on the PM for updates.

CAPA and Audit responses

Investigated CAPA findings and submitted responses and if necessary developed the corrective action plan

Met with auditors for program audits and evaluated the issues and responses

Boston Biomedical, Inc.

Manager of Data Management (Sponsor/Contract) April 2015 to May 2016

(Phase I/IIb Oncology Trials)

Provided leadership for the clinical data management department. Established standards and processes for seventeen trials on three different platforms. Some historical trials were a mixture of paper, RDC, and EDC.

DM Management Contributions

Provided leadership for all aspects of the department. This included many processes for regulatory compliance

Set up data entry and query processes to accommodate the large volume that was needed for the paper trials

Provided guidance and training for different level of resources

Ensured knowledge transfer for staff transitions

Created gap analysis, resource planning and a project plan for several large projects

Data Analyst Functions

Gathered and created the data requirements from the major stakeholders for 2 phase I/II trials

Created the oncology database trial design standards to be used as a template for future trials

Created all the documentation needed for database builds and amendments

Worked with the vendor team to communicate the specs and handle any issues that they may have

EDC system used: InForm 6.1, CLIN Plus and eCaselink EDC Systems

Medical Dictionary Coder for all trials on the three platforms

Established the contract/specs for MedDRA and WHO coding functions with a vendor on two of the platforms

Performed in-house coding utilizing the InForm central coding tool in the InForm platform

Worked with the vendor to clean up the tool and set standards across the six trials

Reporting

Designed and created reporting specs that were needed for the InForm trials

Sr. Management power presentations for various projects

Medivector, Inc.

Lead Data Manager (CRO/Contract) Sept 2014- Feb 2015

(Influenza Trials)

Successfully managed three pivotal trials for the Sponsor.

Point person for triaged issues with various departments and sites

Collaborated with Clinical Affairs to streamline process between the two departments

Authored the communication plan with various parties concerned

Responsible for CRO subcontracted CRO management, timelines and metrics for all parties involved

Worked with the clinical teams to create and manage metrics for Sr. Management

Handled all safety databases and reconciliation with the main databases

EDC system used: Socrates

Cytel, Inc.

Senior Clinical Data Manager (CRO/Contract) Sept 2013 – Sept 2014

(Kidney and Oncology Trials)

Implemented a new trial in RAVE and took on the responsibility of an ongoing trial in InForm. The ongoing trial had a major protocol amendment which changed the database by 30%.

Project Management Contributions to the Clinical Team

Created the Project Management Plan and managed the timeline for the trials

Created and managed all database activities and metrics for the trial

Presented project and data status for Sr. Management and various meetings

Created all documents needed for the trial, DMP, Safety Plan, eCCGs and training materials for various levels

Served as the lead person to resolve any database issues

Vendor management for various functions

Database Development

Established the programed and manual edit checks to support primary and secondary end points

Gathered requirements from the sponsor to design a database that would support a major protocol amendment

All UAT was created and done to meet sponsor’s requirements

EDC system used: InForm ver. 5.6 and RAVE

Standard Data Management

Created the DVS and performed all manual data cleaning functions

SAE Reconciliation with the safety database

Reconciliation with other central lab databases

MedDRA and WHO coding

Reporting

Designed and created all reporting necessary for the study utilizing BI Cognos tools

Excel, MS Access, SAS and Power Point were utilized according to need where BI Cognos tools didn’t meet the requirement

Identified and presented trends in the data which led to change of database or training issue

Designed, created and ran the weekly summary dashboard reports for the team

Trained clinical research associates to look for data entry issues

TransMedics, Inc.

Sr. Clinical Data Manager (Team Lead) (Sponsor/Perm) March 2010– March 2013

Created a Data Management department and provided guidance and leadership for the execution, collection and handling of all clinical data. Successfully launched two phases 2, three trials and one registry in medical device.

Project Management Contributions to the Clinical Team

Managed several CRO vendors involved in the trials

Drove several legacy trials to final database lock and final submittal

Developed the data management plan, protocol, sample logistics etc. from scratch

Created and established all training materials necessary for data management, data verification and for the data collection processes

Created and maintained all data review guidelines for every trial

Mentored and developed two direct reports and several others in a matrix environment

Managed CROs for database build and other data management activities

Organized the timelines and process flow to get a IRB approval, site supplies, training and presentations to PIs

Database Development

Developed the CRFs, edit checks, conducted UAT, created work instructions and SOPs for all data management activities

Wrote specifications for case report forms, edit checks and custom functions for the vendor to build

Ensured CDISC and SDTM standards were implemented by the vendor

Evaluated IVRS for Randomization

Managed the safety database required for the trials in collaboration with clinical

Managed meetings with the CEO/VP to view the prototype database builds

Certified as Architect Builder in the Medidata Rave system

Successfully implemented Medidata RAVE EDC system

Reporting

Created all tables and graphs for various submissions and presentations

Developed report specifications, created and tested the reports to end user’s needs (BOXI)

Designed Dashboards for primary and secondary endpoints, enrollment, metrics etc. (BOXI and Excel)

Prepared all information for investors, board of directors and conferences

Syndax Pharmaceuticals, Inc.

Sr. Clinical Database Manager (Sponsor/Contract) Sept 2009– March 2010

(Oncology Trials)

Lead Data Manager for phase 2 and 3 trials for drug development for oncology studies

Managed CRO responsible for trials who managed their vendors

Developed and updated the safety database with the clinical affairs group

Served as the team lead for the coordination of the Medical Monitor and CRAs

Responsible for mentoring two Data Managers and performed data cleaning

Experienced working with Nextrial’s EDC system

Accenture CRO global onsite / Wyeth Pharmaceuticals, Inc.

Clinical Data Project Manager (CDPM) (CRO/Perm) Dec 2007 – March 2009

(Oncology & Biologics Trials)

Managed up to five Phase 3 large global trials. Locked one legacy system that started on paper in another country. Accenture had the global contract for all data management functions.

Effectively established relationships and reviewed specifications for data uploads for seven different vendors

Drove the process to manage several large phases three trials for the data management teams

Mentored two team leads and instructed them on how to manage a team of nine data managers in India

Solved escalated issues that the team couldn’t solve

Provided the metrics on the progression of the trial

Served as the operational manager for two legacy trials which were closed out

Primary contact lead for several audits of the trials working with the regulatory group, FDA, EMEA, clients, sites, and internal

EDC: Oracle Clinical EDC and RDC System

Dana Farber Cancer Institute

Sr. Clinical Systems Manager (Sponsor/Perm) Nov 2003– Nov 2007

(Hematology)

Implemented a cGMP software system used for manufacturing hematopoietic related products to meet high risk direct patient care needs.

Developed the operational plan together with the Partners Healthcare IT team. This was a biologic lab responsible for production of high-risk bone marrow transplants for five area hospitals.

Project Management Responsibilities

Created the overall implementation resource plan and set timelines

Managed various vendors on this project

Created risk assessment and contingency planning due to high risk direct patient care setting

Mentored two data coordinators and several technicians through various trials

Team lead on the project and audited various vendors implementation sites

Evaluated the feasibility and cost benefit for each program

Established data management activities

Software / Database Implementations

Evaluated different cGMP programs to meet the scope and objectives

Developed the request for proposal (RFP)

Established a design to meet the needs of the end user with the final selection

Created a prototype for the cGMP program prototype and submitted to Sr. Management for final approval

Created validation edit checks used for data cleansing

Successfully implemented Honeywell’s (“POMSNET” Software)

University of Massachusetts

Clinical Data Manager/ Data Analyst (Research/ Perm) July 1988– March 2003

(Hematology Oncology /Gene Therapy)

These positions covered pre-clinical and phase1 oncology clinical trials and grant funded basic research

Lab Manager

Proactively identified, analyzed, and resolved project issues; related to budgeting, ordering, timeline adherence, internal and external communications, and project deliverables

Bio Statistical Analyst

Generated for publications, posters and grants

Analyzed the impact of different outcomes have on the questions at hand

Data generation, recording, researching and verifying for accuracy, graphing, statistical analysis, and presentation

Assisted in writing grants, publications, presentations, posters including creating tables and graphs from raw data

Software Implementation Manager/Business Analyst

Software consulting, specialty programs for gene sequencing, microscope image analysis, databases and selecting computer equipment and software used to improve operational efficiency

Created a MS Access based clinical trials data base for phase 1 and 2 with the necessary forms associated tables and queries

EDUCATION

(previous Name: Helen Valinski)

Nichols College, MA

Master of Business Administration, (MBA)

Assumption College, MA

Bachelors of Arts, Major in Biology

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