Eliassen Group - JOB SEEKERS: eClinical Jobs of the Week

JOBS OF THE WEEK

[53977]  Expert Senior Clinical Data Manager
[54900]  Mid to SR Clinical Data Manager
[53379]  Principal Technical Consultant
[49980]  SAS Programmer - MA, CT and 4-6 years experience

[53977] Expert Senior Clinical Data Manager
Duration: 12 Months Job Description: About Eliassen eClinical Solutions Division (ECSD): Our fast-growing Solutions Provider, located in Mansfield, MA and New London, CT, is a leader in electronic data management solutions for pharmaceutical, biotechnology and medical device companies. The Division’s experienced data managers offer strategic consulting and technical solutions, training, documentation and implementation of clinical software systems. Respected for the industry experience the entire team offers to sponsors, the eClinical Solutions Division has designed a proprietary quality-assured methodology for clinical trials and a responsive style of interaction with sponsors. ECSD’s combination of clinical trial expertise and industry standards provides the security that all projects are well managed by an experienced service partner. ECSD has grown 123% over the past 2 years. Our low turnover rate of less then 5% attests to the satisfaction of our employees in fulfilling their mission to provide expert solutions in the biopharmaceutical industry. Eliassen’s eClinical Solutions Division staff includes active memberships in the Drug Information Association, Massachusetts, Biotechnology Council, Society for Clinical Data Management, eClinical Forum, CDISC, and ASTD. Consider these opportunities: • Come be part of a team that includes, on average, 15 years of experience from all aspects of data management within the Biopharmaceutical world. Help solve client pain points across therapeutic areas in biopharmaceutical companies of all sizes. • Work with colleagues who regularly appear in industry events and work on industry boards including the eClinical Forum and DIA Peach Validation Committee. • Work in a partnering role with Medidata Solutions, a global leader in electronic clinical data capture (EDC), management and reporting solutions. ECSD was the first of their partners to earn the highest level of accreditation in Medidata’s partner program, ASPire to Win®. As a Rave Accredited Plus partner, Eliassen Group can offer the full suite of Rave-related services, including study build, end user training and advanced development and reporting services. • Collaborate with our in-house training team on client projects to ensure knowledge transfer within the sponsor environment. • Contribute to quality deliverables by customizing solutions for bio-pharma clients. • Be part of a continuous learning environment where ongoing training and career development are part of the culture. Expert Senior Data Manager will be responsible for • Overseeing and participating in data management trial start-ups, conduct and close activities. • Performing project consulting activities ensuring high degree of quality and efficiency. • Creating and maintaining applicable DM study documentation, and participating in meetings, both internal and external on client projects. • Supervising DM activities as applicable, addressing clients’ ad hoc requests, and ensuring compliance with industry quality standards, guidelines and procedures. • Working closely with client, internal managers, marketing, sales and recruiting on project delivery services. • Process assessment, SOP development and training content development as needed. Qualifications: 5+ years of Clinical Data Management experience from a Biopharmaceutical company or CRO. BS, preferably from a life sciences or health related discipline. Must have experience with Case Report Form design, Data Management Plans development, data review, query generation and resolution, quality audits, database locks. Experience with clinical trials phases I-III in multiple therapeutic areas. Familiarity with 21 CFR part 11, ICH/GCP, FDA regulations and CDISC standards. Familiarity with MedDRA and WHODRUG coding dictionaries. Oracle Clinical, I-Review, SAS, SQL, EDC (InForm, RAVE) experience a huge plus. Must be detail oriented, have excellent interpersonal skills, excellent communication skills, time management and project management experience. Must be able to prioritize and be able to work individually with little to no supervision and as a team member. Reports to: Manager, Data Management Solutions. Please send resume to: Jackie Deming, eClinical Recruiter, at jdeming@eliassen.com or call 781-246-1600 x188. Please visit http://www.eliassen.com/home_eclinical.aspx

[53977] Expert Senior Clinical Data Manager

Duration: 12 Months

Job Description: About Eliassen eClinical Solutions Division (ECSD): Our fast-growing Solutions Provider, located in Mansfield, MA and New London, CT, is a leader in electronic data management solutions for pharmaceutical, biotechnology and medical device companies. The Division’s experienced data managers offer strategic consulting and technical solutions, training, documentation and implementation of clinical software systems. Respected for the industry experience the entire team offers to sponsors, the eClinical Solutions Division has designed a proprietary quality-assured methodology for clinical trials and a responsive style of interaction with sponsors. ECSD’s combination of clinical trial expertise and industry standards provides the security that all projects are well managed by an experienced service partner. ECSD has grown 123% over the past 2 years. Our low turnover rate of less then 5% attests to the satisfaction of our employees in fulfilling their mission to provide expert solutions in the biopharmaceutical industry. Eliassen’s eClinical Solutions Division staff includes active memberships in the Drug Information Association, Massachusetts, Biotechnology Council, Society for Clinical Data Management, eClinical Forum, CDISC, and ASTD. Consider these opportunities: • Come be part of a team that includes, on average, 15 years of experience from all aspects of data management within the Biopharmaceutical world. Help solve client pain points across therapeutic areas in biopharmaceutical companies of all sizes. • Work with colleagues who regularly appear in industry events and work on industry boards including the eClinical Forum and DIA Peach Validation Committee. • Work in a partnering role with Medidata Solutions, a global leader in electronic clinical data capture (EDC), management and reporting solutions. ECSD was the first of their partners to earn the highest level of accreditation in Medidata’s partner program, ASPire to Win®. As a Rave Accredited Plus partner, Eliassen Group can offer the full suite of Rave-related services, including study build, end user training and advanced development and reporting services. • Collaborate with our in-house training team on client projects to ensure knowledge transfer within the sponsor environment. • Contribute to quality deliverables by customizing solutions for bio-pharma clients. • Be part of a continuous learning environment where ongoing training and career development are part of the culture. Expert Senior Data Manager will be responsible for • Overseeing and participating in data management trial start-ups, conduct and close activities. • Performing project consulting activities ensuring high degree of quality and efficiency. • Creating and maintaining applicable DM study documentation, and participating in meetings, both internal and external on client projects. • Supervising DM activities as applicable, addressing clients’ ad hoc requests, and ensuring compliance with industry quality standards, guidelines and procedures. • Working closely with client, internal managers, marketing, sales and recruiting on project delivery services. • Process assessment, SOP development and training content development as needed. Qualifications: 5+ years of Clinical Data Management experience from a Biopharmaceutical company or CRO. BS, preferably from a life sciences or health related discipline. Must have experience with Case Report Form design, Data Management Plans development, data review, query generation and resolution, quality audits, database locks. Experience with clinical trials phases I-III in multiple therapeutic areas. Familiarity with 21 CFR part 11, ICH/GCP, FDA regulations and CDISC standards. Familiarity with MedDRA and WHODRUG coding dictionaries. Oracle Clinical, I-Review, SAS, SQL, EDC (InForm, RAVE) experience a huge plus. Must be detail oriented, have excellent interpersonal skills, excellent communication skills, time management and project management experience. Must be able to prioritize and be able to work individually with little to no supervision and as a team member. Reports to: Manager, Data Management Solutions. Please send resume to: Jackie Deming, eClinical Recruiter, at jdeming@eliassen.com or call 781-246-1600 x188. Please visit http://www.eliassen.com/home_eclinical.aspx

[54900] Mid to SR Clinical Data Manager
Duration: 6 Months Job Description: Candidate must have a good understanding of Good Clinical Data Management practices, cross-functional roles and responsibilities. Demonstrates working knowledge and efficient use of EDC systems and processes, familiarity with industry standards. Demonstrates effective communication skills, especially in peer-directed presentations. Able to successfully work on a team and or independently. Displays sound project management skills and ability to prioritize workload. Designs CRFs and CRF completion guidelines with input from Clinical Working Group. Oversees vendor Data Management activities. Reviews and approves the documentation produced by CROs. Responsible for completeness of CDM study documentation. Develops Data Management Plans, Data Entry Guidelines, Data Review Guidelines, and eCRF help text. Develops specifications for eCRFs, Edit Checks, electronic data reconciliation, manual review. Defines Electronic Data Transfer specifications under supervision. Produces, reviews and implements study-specific metrics. Defines and maintains data management study timeline. Performs data review according to the Data Review Guidelines and Formatted Data Review Plan. May provide input regarding project resource requirements and timelines. May review clinical study protocols and provide input.

[54900] Mid to SR Clinical Data Manager

Duration: 6 Months

Job Description: Candidate must have a good understanding of Good Clinical Data Management practices, cross-functional roles and responsibilities. Demonstrates working knowledge and efficient use of EDC systems and processes, familiarity with industry standards. Demonstrates effective communication skills, especially in peer-directed presentations. Able to successfully work on a team and or independently. Displays sound project management skills and ability to prioritize workload. Designs CRFs and CRF completion guidelines with input from Clinical Working Group. Oversees vendor Data Management activities. Reviews and approves the documentation produced by CROs. Responsible for completeness of CDM study documentation. Develops Data Management Plans, Data Entry Guidelines, Data Review Guidelines, and eCRF help text. Develops specifications for eCRFs, Edit Checks, electronic data reconciliation, manual review. Defines Electronic Data Transfer specifications under supervision. Produces, reviews and implements study-specific metrics. Defines and maintains data management study timeline. Performs data review according to the Data Review Guidelines and Formatted Data Review Plan. May provide input regarding project resource requirements and timelines. May review clinical study protocols and provide input.

[53379] Principal Technical Consultant
Duration: 12 Months Job Description: The Principal Technical Consultant (CDISC) will work closely with clients and provide high level consulting services related to statistical programming and CDISC standards. Principal Technical Consultants will manage delivery resources and assure that all client work has met or exceeded client expectations and predetermined profitability levels. The successful candidate will have the knowledge and experience to help the eClinical division develop processes to implement use of CDISC standards internally and for clients. KEY TASKS & RESPONSIBILITIES * Function as a technical lead to lead consulting efforts related to CDISC and related projects. * Lead the SAS Programming activities from a technical perspective. * Work with client clinical trial teams (e.g. creation of analysis datasets, production/validation of output, review of annotated case report forms) as needed. * Provide SAS programming support for different projects as needed. * Manage technical resources to deliver client services. * Ensure compliance with Eliassen and industry quality standards, guidelines and procedures. * Work closely with Recruiting and Sales Teams on staffing and project delivery services. * Other duties as assigned. Skills & Requirements * Minimum 7-10 years of SAS experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role. * Experience with Software Development Lifecycle and User Requirements methodologies. * Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies. * Experience in the development and implementation of statistical programming standards. * Experience using industry standards for database design as defined by Clinical Data Interchange Standards Consortium (CDISC). * Experience with CDISC SDTM and ADaM standards. * Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL; SAS/GRAPH a plus. Experience using SAS Version 8.2 and 9.0. * Excellent analytical, problem solving and organization skills with the ability to work on multiple tasks. * Familiarity with EDC and Clinical Data Management Systems: Rave, Inform, Clintrial, or Oracle Clinical preferred. * Proficiency in Microsoft Office Applications.

[53379] Principal Technical Consultant

Duration: 12 Months

Job Description: The Principal Technical Consultant (CDISC) will work closely with clients and provide high level consulting services related to statistical programming and CDISC standards. Principal Technical Consultants will manage delivery resources and assure that all client work has met or exceeded client expectations and predetermined profitability levels. The successful candidate will have the knowledge and experience to help the eClinical division develop processes to implement use of CDISC standards internally and for clients. KEY TASKS & RESPONSIBILITIES * Function as a technical lead to lead consulting efforts related to CDISC and related projects. * Lead the SAS Programming activities from a technical perspective. * Work with client clinical trial teams (e.g. creation of analysis datasets, production/validation of output, review of annotated case report forms) as needed. * Provide SAS programming support for different projects as needed. * Manage technical resources to deliver client services. * Ensure compliance with Eliassen and industry quality standards, guidelines and procedures. * Work closely with Recruiting and Sales Teams on staffing and project delivery services. * Other duties as assigned. Skills & Requirements * Minimum 7-10 years of SAS experience in Pharmaceutical/Biotechnology industry or equivalent IT consulting role. * Experience with Software Development Lifecycle and User Requirements methodologies. * Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodologies. * Experience in the development and implementation of statistical programming standards. * Experience using industry standards for database design as defined by Clinical Data Interchange Standards Consortium (CDISC). * Experience with CDISC SDTM and ADaM standards. * Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL; SAS/GRAPH a plus. Experience using SAS Version 8.2 and 9.0. * Excellent analytical, problem solving and organization skills with the ability to work on multiple tasks. * Familiarity with EDC and Clinical Data Management Systems: Rave, Inform, Clintrial, or Oracle Clinical preferred. * Proficiency in Microsoft Office Applications.

[49980] SAS Programmer - MA, CT and 4-6 years experience
Duration: 6 Months Job Description: About Eliassen eClinical Solutions Division (ECSD): Our fast-growing Solutions Provider, located in Mansfield, MA and New London, CT, is a leader in electronic data management solutions for pharmaceutical, biotechnology and medical device companies. The Division's experienced data managers offer strategic consulting and technical solutions, training, documentation and implementation of clinical software systems. Respected for the industry experience the entire team offers to sponsors, the eClinical Solutions Division has designed a proprietary quality-assured methodology for clinical trials and a responsive style of interaction with sponsors. ECSD's combination of clinical trial expertise and industry standards provides the security that all projects are well managed by an experienced service partner. ECSD has grown 123% over the past 2 years. Our low turnover rate of less then 5% attests to the satisfaction of our employees in fulfilling their mission to provide expert solutions in the biopharmaceutical industry. Eliassen's eClinical Solutions Division staff includes active memberships in the Drug Information Association, Massachusetts, Biotechnology Council, Society for Clinical Data Management, eClinical Forum, CDISC, and ASTD. Consider these opportunities: o Come be part of a team that includes, on average, 15 years of experience from all aspects of data management within the Biopharmaceutical world. Help solve client pain points across therapeutic areas in biopharmaceutical companies of all sizes. o Work with colleagues who regularly appear in industry events and work on industry boards including the eClinical Forum and DIA Peach Validation Committee. o Work in a partnering role with Medidata Solutions, a global leader in electronic clinical data capture (EDC), management and reporting solutions. ECSD was the first of their partners to earn the highest level of accreditation in Medidata's partner program, ASPire to Win®. As a Rave Accredited Plus partner, Eliassen Group can offer the full suite of Rave-related services, including study build, end user training and advanced development and reporting services. o Collaborate with our in-house training team on client projects to ensure knowledge transfer within the sponsor environment. o Contribute to quality deliverables by customizing solutions for bio-pharma clients. o Be part of a continuous learning environment where ongoing training and career development are part of the culture. SAS Programmer will be responsible for: o Create submission-ready standard data presentations and data sets. o Conduct interim analysis, QC, eSub work, as required. o Understand and plan work to deliver on time with highest quality. o Work with supervisor to balance conflicting priorities. o Develop appropriate QC programs and Run routine QC programs as needed. o Carry out rework as requested by supervisor. Experience Required: o 3+ years of Clinical Trials SAS programming experience. o Experience of extracting, manipulating, summarizing, analyzing and presenting data using SAS procedures. o Experience of SAS/MACRO, SQL, SAS/BASE, SAS/GRAPH and Statistical procedures. o Experience of Clinical data and medical dictionaries and understanding of clinical trials. o Experience with clinical study programming and clinical reporting. o Able to program in Unix environment. o Independent, follow through on assignments able to work with minimal oversight. o Good proactive communication skills. To apply, please send resume to Jackie Deming at jdeming@eliassen.com or call 781-246-1600 x188

[49980] SAS Programmer - MA, CT and 4-6 years experience

Duration: 6 Months

Job Description: About Eliassen eClinical Solutions Division (ECSD): Our fast-growing Solutions Provider, located in Mansfield, MA and New London, CT, is a leader in electronic data management solutions for pharmaceutical, biotechnology and medical device companies. The Division's experienced data managers offer strategic consulting and technical solutions, training, documentation and implementation of clinical software systems. Respected for the industry experience the entire team offers to sponsors, the eClinical Solutions Division has designed a proprietary quality-assured methodology for clinical trials and a responsive style of interaction with sponsors. ECSD's combination of clinical trial expertise and industry standards provides the security that all projects are well managed by an experienced service partner. ECSD has grown 123% over the past 2 years. Our low turnover rate of less then 5% attests to the satisfaction of our employees in fulfilling their mission to provide expert solutions in the biopharmaceutical industry. Eliassen's eClinical Solutions Division staff includes active memberships in the Drug Information Association, Massachusetts, Biotechnology Council, Society for Clinical Data Management, eClinical Forum, CDISC, and ASTD. Consider these opportunities: o Come be part of a team that includes, on average, 15 years of experience from all aspects of data management within the Biopharmaceutical world. Help solve client pain points across therapeutic areas in biopharmaceutical companies of all sizes. o Work with colleagues who regularly appear in industry events and work on industry boards including the eClinical Forum and DIA Peach Validation Committee. o Work in a partnering role with Medidata Solutions, a global leader in electronic clinical data capture (EDC), management and reporting solutions. ECSD was the first of their partners to earn the highest level of accreditation in Medidata's partner program, ASPire to Win®. As a Rave Accredited Plus partner, Eliassen Group can offer the full suite of Rave-related services, including study build, end user training and advanced development and reporting services. o Collaborate with our in-house training team on client projects to ensure knowledge transfer within the sponsor environment. o Contribute to quality deliverables by customizing solutions for bio-pharma clients. o Be part of a continuous learning environment where ongoing training and career development are part of the culture. SAS Programmer will be responsible for: o Create submission-ready standard data presentations and data sets. o Conduct interim analysis, QC, eSub work, as required. o Understand and plan work to deliver on time with highest quality. o Work with supervisor to balance conflicting priorities. o Develop appropriate QC programs and Run routine QC programs as needed. o Carry out rework as requested by supervisor. Experience Required: o 3+ years of Clinical Trials SAS programming experience. o Experience of extracting, manipulating, summarizing, analyzing and presenting data using SAS procedures. o Experience of SAS/MACRO, SQL, SAS/BASE, SAS/GRAPH and Statistical procedures. o Experience of Clinical data and medical dictionaries and understanding of clinical trials. o Experience with clinical study programming and clinical reporting. o Able to program in Unix environment. o Independent, follow through on assignments able to work with minimal oversight. o Good proactive communication skills. To apply, please send resume to Jackie Deming at jdeming@eliassen.com or call 781-246-1600 x188