Global Study Analyst

Position code: 4285 Position Title: Global Study Analyst



Work Location: New Jersey - Nutley Corporate Headquarters



Major Responsibilities:

The Global Study Analyst or Global Clinical Operations Coordinator (GCOC) is a member of the Headquarters division and is responsible/accountable for supporting the daily

Clinical Operations functions for a study or series of studies within a project. The GCOC applies knowledge of

clinical development processes to support the Global Study Manager (GSM), the Global Clinical Operations

Associate (GCOA), Study Management Team (SMT), and global business goals.

Principal Responsibilities

General:

? Provide Global Study Manager (GSM)/SMT with regular status updates.

? Act as a liaison with international Roche/CRO monitors to ensure consistent conduct of study across countries.

? Actively participate at SMT meetings and produce meeting minutes as required.

? May participate in the interview process for team members as appropriate.

? Provide direction and mentoring to GCOA, GCOC, and administrative support as appropriate.

? May act as back-up to the GCOA.

? Act as a liaison with contract research organization CRO and/or external service providers as required.

Study Start-Up:

? Assist the SMT in the development of the protocol and the informed consent.

? Assist in the development, collection and collation of data for feasibility testing.

? Manage the flow of essential documents to appropriate archives and create spreadsheets to track information.

? Provide information and/or relevant documents for the required documentation for the IND submission

package.

? Obtain, review, process, and track study documentation including but not limited to informed consents,

regulatory documentation, etc.

? Assist in the development and maintenance of the Study Specific Procedures Manual (SSPM).

? Coordinate aspects of the global investigator/monitor meetings and workshops including preparing and

compiling presentation materials, creating the design layout, and communicating issues as appropriate. May

conduct presentations at these meetings.

? Coordinate the management of all global drugs throughout the trial utilizing the Investigational Supply System

(ISS) or applicable system (ascertains packaging requirements, prepare and track drug packaging and shipment

requests). May include familiarity of import and export requirements along with retest/expiry and

destruction/return procedures.

Study Implementation and Conduct:

? Review data for sites in study including line listings and edit checks; determine accuracy and consistency of

standards.

? Identify data issues and data trends; resolve simple data problems; interact with CTM to obtain resolution;

interact with GSM and/or GCOA to resolve complex issues and potential safety problems.

? Review data flow; analyze modules for transmission error and resolve issues.

? Review CRFs in Intercept station for accuracy, completeness, cross-field checks, and logic checks.

? Manage the ordering and distribution of study specific supplies and equipment globally throughout the trial.

? Assist with the coordination activities for SMT with central laboratories and randomization organizations.

? Create and manage tracking systems for SMT related to drug supply use and return, enrollment and drop out of

subjects, regulatory document flow, financial information, global serious adverse events, etc. to ensure study

timelines are met.

? Assist in the development and distribution of the study newsletters to countries as needed.

? Manage global drug ordering, shipping, tracking, and familiarity of import/export requirements. May include

retest/expiry and destruction/return.

? Manage the distribution of notification of 15-day alerts and annual IDB updates to all investigators on program;

assist GCOA with SAEs.

? Maintain study management documentation (protocol amendments, new investigators, IRB renewals, etc).

? Ensure that essential documents are sent to PDR-CDC (Pharma Development Regulatory-Central Document

Center) utilizing AIMS and interact with archive staff as needed.

Study Close-Down:

? With SMT, assist with activities related to closure of database.

? Ensure that study files are complete (both the PDR-CDC and team files) and all essential documents are

prepared for audit.

? Participate with SMT in Advisory Committee preparation and development of presentation materials.

Qualifications:

- Bachelor?s degree, preferably in science, nursing, other biomedical discipline, or equivalent.

? Training in biomedical field or 3-5 years relevant experience in a clinical trial environment preferred.

? Detail oriented with the ability to work independently and manage multiple competing priorities.

? Ability to efficiently perform multiple complex tasks.

? General knowledge of medical/scientific terminology.

? Familiarity of regulatory requirements and/or ICH/GCP guidelines.

? The demonstration of the professional values and personal skills necessary for effective teamwork.

? Knowledgeable in all aspects of the drug development process.

? Excellent verbal and written communications skills including the ability to state opinions clearly, ask questions,

and seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to

resolution.

? Computer literate in a Windows environment with a working knowledge of the AIMS database desirable.