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Lead Clinical Study Management

Alpha Consulting Corporation

Location:
Wilmington, DE
Posted Date:
6/25/2014
Position Type:
Part time
Job Code:
14-00572
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:
Pharmaceutical,

Job Description

LEAD CLINICAL STUDY MANAGEMENT

REQUIREMENT #14-00572
RECRUITER:  BRIDGET BURNS
JOB LOCATION:  WILMINGTON, DE
JUNE 25, 2014

*** CANDIDATES MUST BE ABLE TO WORK ON OUR PAYROLL AS A W-2 ***

Project Description:  
To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with the client’s Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), LSTL is expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that LSTL manages both roles.
LSTL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

•   Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA
•   Lead Local Study Team(s) consisting of monitors and study administrator(s)
•   Lead and optimize the performance of the local Study Team(s) at country level ensuring compliance with the client’s Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
•   Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team
•   Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters
•   Proactively identify and facilitate resolution of complex study problems and issues
•   Organize regular Local Study Team meetings on an agenda driven basis
•   Actively work towards achieving good personal relationships with all local Study Team members
•   Report study progress/update to the SMO Study Leader / Team
•   Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary
•   Communicate and co-ordinate regularly with National Co-coordinating Investigator / National Lead Investigator on recruitment and other study matters
•   Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals / sites
•   Plan and lead national Investigator meetings as needed, in line with local codes
•   Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs
•   Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan
•   Ensure timely preparation of country SMA, fSMA and Master CSA
•   Ensure completeness of the Study Master File and ensure essential documents are sent to SMO / Hub location / site
•   Ensure local Serious Adverse Event (SAE) reconciliation takes place
•   Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers
•   Ensure timely submission of proper application / documents to EC / IRB
•   Work together with Regulatory Affairs to ensure timely delivery of proper application / documents for submissions to Regulatory Authority
•   Set up and maintain the study in IMPACT at study country level
•   Ensure accurate payments related to the study are performed
•   Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH / GCP and the client’s Procedural Documents
•   Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File
•   Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and CA&A
•   Provide input to process development and improvement
•   Provide regular information to Line Managers (SMM Director / CRM) at country level on studies and planned study milestones / key issues
•   Update Line Managers (SMM Director / CRM) about the performance of the monitors / CRAs
•   Ensure that study activities at country level comply with local policies & code of conduct

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com

Requirements


•   Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA
•   Lead Local Study Team(s) consisting of monitors and study administrator(s)
•   Lead and optimize the performance of the local Study Team(s) at country level ensuring compliance with the client’s Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
•   Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team
•   Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters
•   Proactively identify and facilitate resolution of complex study problems and issues
•   Organize regular Local Study Team meetings on an agenda driven basis
•   Actively work towards achieving good personal relationships with all local Study Team members
•   Report study progress/update to the SMO Study Leader / Team
•   Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary
•   Communicate and co-ordinate regularly with National Co-coordinating Investigator / National Lead Investigator on recruitment and other study matters
•   Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals / sites
•   Plan and lead national Investigator meetings as needed, in line with local codes
•   Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs
•   Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan
•   Ensure timely preparation of country SMA, fSMA and Master CSA
•   Ensure completeness of the Study Master File and ensure essential documents are sent to SMO / Hub location / site
•   Ensure local Serious Adverse Event (SAE) reconciliation takes place
•   Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers
•   Ensure timely submission of proper application / documents to EC / IRB
•   Work together with Regulatory Affairs to ensure timely delivery of proper application / documents for submissions to Regulatory Authority
•   Set up and maintain the study in IMPACT at study country level
•   Ensure accurate payments related to the study are performed
•   Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH / GCP and the client’s Procedural Documents
•   Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File
•   Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and CA&A
•   Provide input to process development and improvement
•   Provide regular information to Line Managers (SMM Director / CRM) at country level on studies and planned study milestones / key issues
•   Update Line Managers (SMM Director / CRM) about the performance of the monitors / CRAs
•   Ensure that study activities at country level comply with local policies & code of conduct

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