Project Administrative Assistant

Sharon M. DeLande

**** ******** **** **** *****: 908-***-****

Plainfield, NJ 07060 **********@*****.***

QUALIFICATIONS SUMMARY

Clinical Research Professional with proven success in efficiently managing

regulatory documents from start up to close out. Exhibits excellent

attention to detail; reviews and evaluates files for quality, accuracy,

completion and compliance with regulatory guidelines. Skilled at working

collaboratively with associates world-wide to facilitate information,

payments, and supplies. Ten years of Pharmaceutical Industry experience

provides the foundation for solid industry understanding and continued

career success.

Core Competencies

Clinical Trials - Site Feasibility & Start-Up - Documentum -

Regulatory Compliance - Communication

Regulatory Documentation - SharePoint - eRoom - ICH & GCP Practices -

Payment Systems - LMS

IMPACT - eTMF - ISI Toolbox - OPX2 - Watson - LIM system - Microsoft

Office Suite - Microsoft Project

Therapeutic Areas

Allergy/ Respiratory - Neurology - Oncology - Pain/Pain Management

Endocrinology/Diabetes - Device

EDUCATION:

Bachelor of Arts, Liberal Studies - Thomas Edison State College 2008

Primary Course Focus on Health Related Sciences - College of Saint

elizabeth 2004-2007

AWARDS & RECOGNITION:

September 2013 - Award for Excellence (Allergan)

April 2012, September 2011, May 2011 - Certificate of Recognition for

achievement and contribution to a study (RPS)

December 2007 - Shining Performance Award (Schering-Plough)

March 2004 - Special Achievement Award for outstanding contributions

towards a project (sanofi-aventis)

TRAINING COURSES:

November 2013 - 5 Choices for extraordinary productivity - 1 day Workshop

August 2013 - The Successful Negotiator - Ira ASHERMAN 2 day Workshop

EXPERIENCE:

Allergan, Bridgewater NJ JAN 2013 - Present

Sr. Clinical Study Specialist

Develops, evaluates, and executes all essential clinical trial documents,

budgets, and clinical trial agreements (CTAs). Aligns execution activities

with agreed upon project priorities, timings and quality specifications.

Adheres to all relevant regulations including ICH and PhRMA guidelines and

Allergan's SOPs and policies.

> Responsible for the logistical tasks associated with the preparation,

collation and review of the regulatory documents submission package

> Ensures distribution of draft essential documents to the selected sites

> Responsible for drafting and reviewing of Study ICF; Responsible for the

development of the Country-specific Informed Consent template by adapting

the Study ICF templates with country-specific requirements

> Confirms the drug release documents are received in-house and follows-up

with site if documents are missing or incomplete; Responsible for on-

going regulatory document maintenance

> Responsible for the preparation, review, confirmation and distribution of

the draft Clinical Trial Agreement and Budget to Site

> Responsible for the Negotiation with site on budget costs and contract

language

Sharon M. DeLande - PAGE 2

EXPERIENCE (CONTINUED):

> Ensure follow-up with site if documents are missing or incomplete;

tracking document status within IMPACT

> Ensure the preparation of the final Clinical Trial Agreement and budget

and route for signature. Ensure the distribution of final documents as

appropriate. Responsible for managing amendments to the CTAs as necessary

> Assemble & QC CSSA Checklists within FirstDoc, and route for electronic

signatures as needed

> Meet regularly with Study Team to review site status, and resolve study

or site issues.

RPS for Janssen Research & development LLC., Raritan, NJ JAN 2009 -

JAN 2013

Investigator Document Associate

Provides timely and consistent support in handling a variety of duties

associated with clinical trial documentation; provides detailed and

diligent support to Trial Managers and regionally based Site Managers;

collects and reviews regulatory documents; ensures accuracy and

completeness.

> Integral team member involved with FDA audit preparation/inspection for

new submission

> Distributes and tracks Feasibility Questionnaires and Confidentiality

Disclosure Agreements; cross-checks investigators against FDA, OAI, and

debarment list; reviews and secures approval of changes to informed

consent with regulatory personnel.

> Ongoing Trial Master File reconciliation for all regulatory documents

collected and updated. Maintains site tracking spreadsheets.

> Tracks and maintains site information including, CTMS, and safety

reporting tool; assembles Trial Center File binder; distributes final

versions of all documents to site and assist with Central IRB

submissions.

> Scans and loads documents to eTMF according to process guidelines;

Collaborates with the Central Import Group to handle large volume

document scanning projects.

> Liaises with Site Managers and Trial Managers to resolve study or site

issues.

> Utilizes exceptional organizational skills to far exceed the weekly

production average of 3-5 regulatory packets for study startup; delivered

50 regulatory packets to the local trial manager in just over one month.

> Presented at yearly Team meeting regarding current role and unique

experiences encountered.

> Ongoing mentoring and knowledge sharing with associates.

sanofi-aventis, Bridgewater, NJ OCT 2008- JAN 2009

Clinical Trial Coordinator- Cardiovascular/Thrombosis (Contractor)

Contract position; key contact for facilitation of IST/IIT clinical trial

processes.

> Reviewed Trial Master File for accuracy and completeness; performed

documentation quality control, edits and filing.

> Performed administrative tasks; meeting documentation and distribution to

team.

GE Healthcare Princeton, NJ MAY 2008 - OCT 2008

Clinical Trial Associate- Diagnostic Imaging (Contractor)

Contract position; reviewed TMF documents for regulatory submission;

participated in study team meetings.

> Organized and cross-checked paper documents acquired from overseas

investigator sites against available electronic versions;

> Scanned and Indexed high volume of documents to ensure comprehensive

collection of electronic information.

SCHERING PLOUGH SPRI, Kenilworth, NJ MAR 2006 - MAY 2008

Clinical Trial Coordinator- Allergy/Respiratory

Supported operations, CRAs, and CPSs in U.S & Globally with multiple sites.

> Ensured proper budget set up and timely payments; collaborated with study

team members to resolve payment issues.

> Trained monitors' meeting attendees in payment process and ancillary

supplies; provided feed back to team to assist revision of training

modules to improve understanding and create greater process efficiency.

Sharon M. DeLande - PAGE 3

EXPERIENCE (CONTINUED):

> Identified bulk drug supply and resupply needs, oversaw packaging,

ancillary supplies, and drug shipment; presented clinical processes at

investigators' and monitors' meetings.

> Overcame shipping and staffing issues to meet challenging timelines and

study dates.

> Partnered with project physician and CSM, provide contributions towards

editing and formatting expertise to protocol review team meetings;

collaborated with CPS to assemble and process regulatory documentation.

> Liaised with IVRS vendor; assisted with set up and tracked project

throughout study; updated e-rooms; processed, submitted and signed off on

multiple study documents in ClinDoc.

> Received a Shining Performance Award for going above and beyond the

normal call of duty; achieved physical study start up within days of the

original timeline despite start up team being one month behind schedule.

sanofi-aventis, (Aventis Pharmaceuticals), Bridgewater, NJ JAN 2002 -

MAR 2006

Global Metabolism and Pharmacokinetics, Logistics-Assistant Specialist

(2005-2006)

Global Metabolism and Pharmacokinetics, Clinical PK-Document Coordinator

(2002-2006)

Key contact for document coordination, technical issues, and all duties

associated with successful execution of clinical studies. US GMPK training

file and quarterly event coordinator.

> Orchestrated documentation processes; assisted with document upload,

folder creation, and template selection; formatted and edited GRESDA

reports; maintained TMF files and archives.

> Received and tracked clinical and pre-clinical samples; contributed to

label templating for PK sample collection; developed and maintained SOPs;

provided training and guidance to section archivists.

> Communicated with CROs to coordinate documentation process; identified

legacy TMF originals and ensured proper archival destination;

> Resolved issues, assisted end users with LMS, entered data into IMPACT

and processed project number requests.

> Received Special Achievement Award for outstanding contribution towards a

major project.

sanofi-aventis, (Aventis Pharmaceuticals), Bridgewater, NJ MAY 2000 -

JAN 2002

Sr. Administrative Assistant/Clinical trial Assistant (Contractor) (2000-

2002)

Global Pharmacovigilance

> Coordinated with Project physicians on Taxotere related projects as

needed; Retrieved/Printed CIOMS forms from ClinTrace

> Edited Periodic Safety Update Reports; Created and Modified Microsoft

PowerPoint presentations, maintained spreadsheets and created word

documents.

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