Senior Research Fellow / Senior Researcher Data Management and Biometrics National University of Ireland, Galway, HRB Clinical Research Facility

NUIG 131-17 Senior Research Fellow / Senior Researcher Data Management and Biometrics, HRB Clinical Research Facility, Galway Applications are invited from suitably qualified candidates for a fixed-term contract position as Senior Researcher Data Management and Biometrics (Research Fellow) to join the HRB-CRFG team. The position is available immediately and the contract is for 1 year initially, with potential to extend subject to project success and funding acquisition. The HRB-CRFG has developed a Biostatistics and Data Management Hub which includes both an extensive biostatistics service and the provision of an integrated data management service. This means seamless clinical data capture, validation, monitoring, storage, processing and archiving powered by the latest clinical research management technology. The post holder will provide professional management and co-ordination of the team, interaction with industry and clinical investigators, assign work and oversee the collation, management and analysis of clinical research data, as well as implementing the latest research-based data management processes as determined by national and international clinical research management bodies. The role will also involve oversight of database building, Case Report Form (CRF) development or amendment, data collection, review and discrepancy management to ensure data quality and consistency and oversight of data management practices. Please see www.crfg.ie for more information on the HRB-CRFG. MAIN PURPOSE OF JOB: This post will require a thorough understanding of the entire clinical research process to anticipate and fulfil the clinical data needs of each study. This will involve working closely with investigators, the clinical data management team and the HRB-CRFG biostatistics team, to devise the data and/or analytic requirements based upon a study proposal or protocol. The post-holder provides oversight of all biostatistics and clinical data management processes and Standard Operating Procedures (SOP) including the allocation of staff to research projects, monitoring and balancing staff workload, integrating the biostatistics and data management services and processes, creation of CRFs, electronic databases, Data Management Plans (DMP) and files for a portfolio of studies. The post will also involve communication with external research centres nationally, to manage the collation of research data and preparation of periodic reports. A variety of clinical trial and registry development tools (iDataFax, InferMed and MACRO, etc) are utilised in the HRB-CRFG and proficiency in this area is an advantage. It is the responsibility of the Senior Researcher Data Management and Biometrics (Research Fellow) to manage and coordinate the daily activities of the Biostatistics and Data Management teams. The Senior Researcher Data Management and Biometrics (Research Fellow) will plan for and resolve any issues that may occur in the capturing the data (in electronic format) ensuring that high quality data is delivered for analysis in an accurate and efficient fashion, and address any issues that arise during biostatistical review and analyses of data. The post requires a thorough knowledge and understanding of the policy, practices and procedures relevant to the role, and provision of advice to junior colleagues on policy and standards relating to biostatistics and clinical data management. The role will involve oversight of processes to assure data integrity and confidentiality for regulated clinical trials and knowledge of this area would be an advantage, although not essential. The post holder will be expected to contribute and support the development of research grant funding submissions by coordinating and providing advice on biostatistics, data management, budgets and timelines. MAIN DUTIES AND RESPONSIBILITIES: Liaison with the CRFG management team with regard to the delivery of and long-term development of biostatistics and clinical data management services. Management of the Biostatistics and Data Management teams, oversight of operations and assurance of quality of outputs. Co-ordinate the work of the biostatistics and data management teams. Organise and conduct meetings with staff members to clarify objectives, develop team work plans/timetables for external entities, and communicate progress. Review, analyse, and validate plans for clinical research data collection, collations and analysis to ensure consistency, integrity and accuracy based on project specific guidelines in preparation for abstract submissions/publications Support HRB-CRFG research funding submission process by providing guidance on biostatistics and clinical data management aspects. Review and contribute to the study feasibility process, at the point of selection of studies to be undertaken by the HRB-CRFG. Assess and provide costing estimates for biostatistics and data management aspects of clinical research studies proposed for the HRB-CRFG and affiliates. Contribute to the design/review of the study protocol and provide input to the clinical trial team on aspects of biostatistics and data management. Oversee the design of CRFs and associated completion guidelines. Ensure effective management of their generation and quality control. Present material for clinical trial activities at investigator meetings and site initiation visits. Assist with the development of training programs for investigators and research staff in biostatistics and data management. Provide expert advice on aspects of biostatistics and data management to research fellows and other colleagues and play a leadership role for junior colleagues Define database requirements and data validations. Develop and implement quality assurance measures in data management. Development of reports to track participant accruals and associated metrics nationally. Prepare statistical analysis plans and/or data management plans as they pertain to specific studies. Generate accurate data clarification requests and track all queries through to their resolution. Appreciate and apply the legal requirements regarding data protection and confidentiality data protection requirements. Ensure appropriate and timely communications with investigative sites in the collection, entry, management, quality control and analysis of data, as required by investigators and sponsors. Develop and ensure adherence to HRB-CRFG Standard Operating Procedures (SOPs). Engage in appropriate training and professional development opportunities as required by the Principal Investigator, the HRB-CRFG, Saolta and NUI Galway. Any other duties relevant to this post which may arise and as requested by the HRB-CRFG Director. The post holder requires University degree or equivalent professional qualification, and relevant work experience in a clinical research biostatistics or data management related role. Minimum of 3 years’ experience in team management and oversight of team operations. Knowledge of clinical research or similar, associated processes and regulations. Strong communication skills. Effective organisational skills and detail orientated. Able to demonstrate a good and confident command of spoken & written English, sufficient to successfully discuss and explain complex technical ideas in simple & concise terms to a diverse range of stakeholders Ideally the post holder will have Clinical or life science qualification An IT qualification Salary range: €63,125 to €65,032 per annum. NB: Gárda clearance is a requirement for this post (as appropriate to Child Protection Policy) Continuing Professional Development/Training: Researchers at NUI Galway are encouraged to avail of a range of training and development opportunities designed to support their personal career development plans. Further information on research and working at NUI Galway is available on Research at NUI Galway For information on moving to Ireland please see www.euraxess.ie Further information about HRB CRFG is available at crfg.ie Application Procedure: Applicants should send a covering letter, detailed CV and the names and addresses of at least three referees via e-mail (in Word or PDF format only) to: crfg@nuigalway.ie Applicants must put Ref. No. NUIG 131-17 in subject line of e-mail application The closing date for receipt of applications is 5pm on Friday 8th September 2017. A panel may be formed for future posts. All positions are recruited in line with Open, Transparent, Merit (OTM) and Competency based recruitment National University of Ireland, Galway is an equal opportunities employer Closing Date: Friday, 08 Sep 2017 Application: NUIG 131-17 Senior Research Fellow / Snr Researcher Data Management & Biometrics If you apply for this position please say you saw it on Computeroxy Apply

NUIG 131-17 Senior Research Fellow / Senior Researcher Data Management and Biometrics, HRB Clinical Research Facility, Galway

Applications are invited from suitably qualified candidates for a fixed-term contract position as Senior Researcher Data Management and Biometrics (Research Fellow) to join the HRB-CRFG team. The position is available immediately and the contract is for 1 year initially, with potential to extend subject to project success and funding acquisition.

The HRB-CRFG has developed a Biostatistics and Data Management Hub which includes both an extensive biostatistics service and the provision of an integrated data management service. This means seamless clinical data capture, validation, monitoring, storage, processing and archiving powered by the latest clinical research management technology. The post holder will provide professional management and co-ordination of the team, interaction with industry and clinical investigators, assign work and oversee the collation, management and analysis of clinical research data, as well as implementing the latest research-based data management processes as determined by national and international clinical research management bodies. The role will also involve oversight of database building, Case Report Form (CRF) development or amendment, data collection, review and discrepancy management to ensure data quality and consistency and oversight of data management practices.

Please see www.crfg.ie for more information on the HRB-CRFG.

MAIN PURPOSE OF JOB:

This post will require a thorough understanding of the entire clinical research process to anticipate and fulfil the clinical data needs of each study. This will involve working closely with investigators, the clinical data management team and the HRB-CRFG biostatistics team, to devise the data and/or analytic requirements based upon a study proposal or protocol. The post-holder provides oversight of all biostatistics and clinical data management processes and Standard Operating Procedures (SOP) including the allocation of staff to research projects, monitoring and balancing staff workload, integrating the biostatistics and data management services and processes, creation of CRFs, electronic databases, Data Management Plans (DMP) and files for a portfolio of studies. The post will also involve communication with external research centres nationally, to manage the collation of research data and preparation of periodic reports.

A variety of clinical trial and registry development tools (iDataFax, InferMed and MACRO, etc) are utilised in the HRB-CRFG and proficiency in this area is an advantage. It is the responsibility of the Senior Researcher Data Management and Biometrics (Research Fellow) to manage and coordinate the daily activities of the Biostatistics and Data Management teams. The Senior Researcher Data Management and Biometrics (Research Fellow) will plan for and resolve any issues that may occur in the capturing the data (in electronic format) ensuring that high quality data is delivered for analysis in an accurate and efficient fashion, and address any issues that arise during biostatistical review and analyses of data. The post requires a thorough knowledge and understanding of the policy, practices and procedures relevant to the role, and provision of advice to junior colleagues on policy and standards relating to biostatistics and clinical data management. The role will involve oversight of processes to assure data integrity and confidentiality for regulated clinical trials and knowledge of this area would be an advantage, although not essential. The post holder will be expected to contribute and support the development of research grant funding submissions by coordinating and providing advice on biostatistics, data management, budgets and timelines.

MAIN DUTIES AND RESPONSIBILITIES:

Liaison with the CRFG management team with regard to the delivery of and long-term development of biostatistics and clinical data management services.
Management of the Biostatistics and Data Management teams, oversight of operations and assurance of quality of outputs.
Co-ordinate the work of the biostatistics and data management teams. Organise and conduct meetings with staff members to clarify objectives, develop team work plans/timetables for external entities, and communicate progress.
Review, analyse, and validate plans for clinical research data collection, collations and analysis to ensure consistency, integrity and accuracy based on project specific guidelines in preparation for abstract submissions/publications
Support HRB-CRFG research funding submission process by providing guidance on biostatistics and clinical data management aspects.
Review and contribute to the study feasibility process, at the point of selection of studies to be undertaken by the HRB-CRFG.
Assess and provide costing estimates for biostatistics and data management aspects of clinical research studies proposed for the HRB-CRFG and affiliates.
Contribute to the design/review of the study protocol and provide input to the clinical trial team on aspects of biostatistics and data management.
Oversee the design of CRFs and associated completion guidelines. Ensure effective management of their generation and quality control.
Present material for clinical trial activities at investigator meetings and site initiation visits.
Assist with the development of training programs for investigators and research staff in biostatistics and data management.
Provide expert advice on aspects of biostatistics and data management to research fellows and other colleagues and play a leadership role for junior colleagues
Define database requirements and data validations.
Develop and implement quality assurance measures in data management.
Development of reports to track participant accruals and associated metrics nationally.
Prepare statistical analysis plans and/or data management plans as they pertain to specific studies.
Generate accurate data clarification requests and track all queries through to their resolution.
Appreciate and apply the legal requirements regarding data protection and confidentiality data protection requirements.
Ensure appropriate and timely communications with investigative sites in the collection, entry, management, quality control and analysis of data, as required by investigators and sponsors.
Develop and ensure adherence to HRB-CRFG Standard Operating Procedures (SOPs).
Engage in appropriate training and professional development opportunities as required by the Principal Investigator, the HRB-CRFG, Saolta and NUI Galway.
Any other duties relevant to this post which may arise and as requested by the HRB-CRFG Director.

The post holder requires

University degree or equivalent professional qualification, and relevant work experience in a clinical research biostatistics or data management related role.
Minimum of 3 years’ experience in team management and oversight of team operations.
Knowledge of clinical research or similar, associated processes and regulations.
Strong communication skills.
Effective organisational skills and detail orientated.
Able to demonstrate a good and confident command of spoken & written English, sufficient to successfully discuss and explain complex technical ideas in simple & concise terms to a diverse range of stakeholders

Ideally the post holder will have

Clinical or life science qualification

An IT qualification

Salary range: €63,125 to €65,032 per annum.

NB: Gárda clearance is a requirement for this post (as appropriate to Child Protection Policy)

Continuing Professional Development/Training:

Researchers at NUI Galway are encouraged to avail of a range of training and development opportunities designed to support their personal career development plans.

Further information on research and working at NUI Galway is available on Research at NUI Galway

For information on moving to Ireland please see www.euraxess.ie

Further information about HRB CRFG is available at crfg.ie

Application Procedure: Applicants should send a covering letter, detailed CV and the names and addresses of at least three referees via e-mail (in Word or PDF format only) to: crfg@nuigalway.ie

Applicants must put Ref. No. NUIG 131-17 in subject line of e-mail application

The closing date for receipt of applications is 5pm on Friday 8th September 2017.

A panel may be formed for future posts.

All positions are recruited in line with Open, Transparent, Merit (OTM) and Competency based recruitment

National University of Ireland, Galway is an equal opportunities employer

Closing Date: Friday, 08 Sep 2017

Application: NUIG 131-17 Senior Research Fellow / Snr Researcher Data Management & Biometrics

If you apply for this position please say you saw it on Computeroxy

Apply