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Mindy Isaacs

Clinical Data Manager (company downsized)

Clinical Data Manager

Greater Boston Area

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Mindy Isaacs's Email Addresses & Phone Numbers

Mindy Isaacs's Work Experience

Molecular Insight Pharmaceuticals

Clinical Data Manager (company downsized)

March 2009 to January 2010

Altus Pharmaceuticals

Clinical Data Manager (company closed)

October 2007 to March 2009

PAREXEL

Clincal Data Manager

September 2000 to September 2007

Mindy Isaacs's Education

Northeastern University

Bachelor of Science (B.S.), Health Management, Magna cum laude

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Mindy Isaacs's Estimated Salary Range

About Mindy Isaacs's Current Company

Molecular Insight Pharmaceuticals

Create the study Data Handling Plan and supporting documents (e.g. SAE reconciliation, CCG’s). Participate in creating edit checks, test data, performing UAT and document findings. Participate in protocol development. Provide feedback on protocol amendments. Liaise with external vendors. Perform data cleaning and manual review. Proactive identification and escalation of issues. Report status for DM activities to study...

Frequently Asked Questions about Mindy Isaacs

What company does Mindy Isaacs work for?

Mindy Isaacs works for Molecular Insight Pharmaceuticals


What is Mindy Isaacs's role at Molecular Insight Pharmaceuticals?

Mindy Isaacs is Clinical Data Manager (company downsized)


What is Mindy Isaacs's personal email address?

Mindy Isaacs's personal email address is m****[email protected]


What is Mindy Isaacs's business email address?

Mindy Isaacs's business email addresses are not available


What is Mindy Isaacs's Phone Number?

Mindy Isaacs's phone (**) *** *** 194


What industry does Mindy Isaacs work in?

Mindy Isaacs works in the Pharmaceuticals industry.


About Mindy Isaacs

📖 Summary

Clinical Data Manager (company downsized) @ Molecular Insight Pharmaceuticals Create the study Data Handling Plan and supporting documents (e.g. SAE reconciliation, CCG’s). Participate in creating edit checks, test data, performing UAT and document findings. Participate in protocol development. Provide feedback on protocol amendments. Liaise with external vendors. Perform data cleaning and manual review. Proactive identification and escalation of issues. Report status for DM activities to study team and management. From March 2009 to January 2010 (11 months) Clinical Data Manager (company closed) @ Altus Pharmaceuticals Oversee data management functions on outsourced studies. Liaise and correspond with vendors. Escalate issues as necessary. Phase I and II Trials: Provide feedback relating to protocol development, vendor selection, CRF design, data management plans and database specifications. Review Protocol Amendments. Perform SAE and IVRS reconciliation. Maintain study files. From October 2007 to March 2009 (1 year 6 months) Clincal Data Manager @ PAREXEL Primary of large Phase III study from study completion and site closeout through database lock. Phase IIB in maintenance and Phase III in set-up. Perform data cleaning including review, query generation, integration, listings and audits to ensure data accuracy, integrity and consistency. Train and QC work for new team members. Integration Lead. From September 2000 to September 2007 (7 years 1 month) Contract Clinical Data Manager @ Alkermes Alkermes Inc., Waltham, MA: Lead Phase III studies from study set-up through database lock. Oversee work performed at vendors. PAREXEL, Billerica, MA: Data and listing review, integration, perform UAT, identify UAT errors. MediVector, Inc., Boston, MA: Lead on Phase III Global Study. Mentor, train and provide guidance to junior staff. Raise study related issues to study team. Perform data cleaning, query generation and integration Veristat Inc., Holliston, MA: Perform data cleaning on oncology trials including review, query generation, integration and listings to ensure data accuracy, integrity and consistency. Perform UAT. Work closely with the lead CDM to communicate and identify findings. Millennium Pharmaceutical, Cambridge, MA: Review and reconcile local lab data; identify, communicate and follow issues through until resolution. Review UAT documentation and outsourced Data Validation Plan (DVP) to ensure compliance with the Protocol. Date review. AMAG Pharmaceuticals, Lexington, MA: Review outsourced data (Phase II) prior to database lock. Report and summarize findings to Associate Director of Data Management. Waltham, MA


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In a nutshell

Mindy Isaacs's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

Average Tenure

3 year(s), 2 month(s)

Mindy Isaacs's Willingness to Change Jobs

Unlikely

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