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Project Manager- Clinical Operations

Location:
Exeter, New Hampshire, 03885, United States
Posted:
March 04, 2011

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Jennifer Dickson Grace

* ******* ***

Stratham, NH

603.***.****

e-mail: xoax7a@r.postjobfree.com

Qualifications:

Thirteen years of clinical research experience (Phase I, II, III, IV) as an Associate Director, Clinical Trial Manager, Lead CRA and Clinical Data Manager.

Both Sponsor and CRO experience

Therapeutic experience includes Diabetes, Oncology (ovarian and breast), Depression, Crohn’s disease, HIV and Cardiology.

Medical writing experience that includes clinical study reports, safety narratives and annual reports.

Working knowledge of Good Clinical Practices.

Excellent written and verbal communication skills.

Professional Experience:

Independent Consultant - December 2010 - Present

Performed quality control of annual reports.

Worked with Sponsor to develop SOPs.

Associate Director, Clinical Operations - CPEX Pharmaceuticals, November 2008 – June 2010

Managed Phase 2 nasal insulin program.

Managed CROs and other vendors.

Developed budgets, metrics and timelines.

Provided strategic input to increase enrollment and meet timelines.

Developed processes, metrics, protocols, and study tools.

Led clinical team to finalization of CSRs of several ongoing Phase 1 trials.

Initiated RFPs from perspective vendors, negotiated contracts and selected vendors.

SOP review and development.

Medical writing experience involved preparing the Clinical Operations section of Annual Report.

Site Visit Consultant- Schulman Associates IRB, August 2007 - June 2009

Conducted annual study site visits per Massachusetts Department of Public Health

Ensured site personnel were following good clinical practices (GCPs).

Ensured site personnel were updating IRB with appropriate regulatory documents in a timely manner.

Verified site personnel were adequately consenting subjects with proper informed consent documents.

Reviewed site standard operating procedures (SOPs).

Contract Global Clinical Trial Manager- MannKind Corp., November 2002 - January 2009

Acted as CTM for several large international Type 1 and Type 2 Diabetes studies.

Managed and finalized site and study budgets.

Performed international co-monitoring visits including international trial audit.

Developed study tools including monitoring plans, monitoring report templates, forms, informed consent forms, and CRF completion guidelines.

Developed study protocols, informed consent form templates, and SOPs.

Initiated RFPs from prospective vendors, attended bid defense and selected vendors.

Interacted with and directed CRO personnel.

Assisted with development and finalization of IMP projection and labels.

Presented at Investigator Meetings.

Managed study timelines including enrollment and data collection.

Performed clinical review of Phase 3 data for safety and efficacy.

Wrote safety narratives.

Performed quality control of Clinical Operations section of Annual Report.

Contract Clinical Scientist- Wyeth, Cambridge, MA, March 2001- November 2002

Performed co-monitoring visits with regional clinical research associated to ensure quality site monitoring and protocol compliance.

Reviewed monitoring reports of regional clinical research associates.

Interacted with study sites to ensure resolution of action items reported in regional CRAs monitoring reports.

Performed internal review of regulatory documents.

Responded to internal quality audit of three international study sites.

Performed site qualification and initiation visits.

Acted as Lead Clinical Scientist on two Crohn’s disease studies.

Reviewed and approved site payment requests.

Tracked, reviewed, and processed Serious Adverse Event reports.

Medical writing of Clinical Study Reports (CSRs).

Contract Lead Clinical Research Associate- PAREXEL International, Waltham, MA, May 2000- March 2001

Acted as Primary Clinical Research Associate on a medical imaging study using remote data entry.

Performed in-house source document verification.

Reviewed Case Report Forms to ensure adherence to protocol specific guidelines per client.

Trained team members on study protocol, source document review and electronic database.

Represented both data management and the clinical department at team meetings to determine

study timelines.

Re-assessed resourcing needs on an ongoing basis.

Trained investigator sites on study protocol and remote data entry tool.

Compiled patient eligibility listings and exemptions for Client.

Clinical Research Associate- CareStat, Inc., Chestnut Hill, MA, October 1999 – May 2000

Performed site qualification, initiation and monitoring visits for a post-marketing study.

Coordinated study start-up activities including site selection and qualification and data management functions.

Reviewed in-house regulatory documents to ensure quality control.

Clinical Research Associate- ASTA Medica, Inc., Tewksbury, MA, May 1999 - September 1999

Conducted co-monitoring visits with decentralized clinical research associates, to assess productivity and monitoring skills.

Reviewed and revised monitoring reports to improve quality and consistency.

Re-monitored a study site as a result of an external audit, in order to ensure clean data and respond to audit action items.

Reviewed monthly expense reports and time sheets for decentralized clinical research associates.

Provided input to finalize corporate Standard Operating Procedures.

Clinical Research Associate- PAREXEL International, Waltham, MA, December 1997 - May 1999

Performed site initiation, monitoring, and termination visits of both pharmaceutical and device clinical trials.

Data collection and quality control of data collected.

Ensured compliance with protocol, SOPs, FDA regulations and GCP/ICH guidelines.

On-site query resolution and verification.

Performed drug accountability and disposition.

Clinical Data Manager- PAREXEL International, Waltham, MA, December 1996 - November 1997

Maintained communication between client and PAREXEL for one protocol of large study.

Reviewed team members’ work to ensure quality and integrity of data and determine training needs.

Reviewed Case Report Forms to ensure adherence to protocol specific guidelines per client.

Query generation to clarify discrepancies in data received from site.

Developed data validation guidelines for various protocols in study.

Education:

M.P.H. – Health Services /International Health – Boston University, Boston, MA, September 1996

B.S. – Health Management and Policy – University of New Hampshire, Durham, NH, May 1991



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