Careers

TITLE: SR. CLINICAL TRIAL ASSOCIATE

DUTIES: Assist in the coordination and administration of clinical studies from start-up to execution and close-out; Set-up and maintenance of ETMF and ISF, including document tracking in accordance with ICH-GCP and local requirements; create and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g., ANGEL), ensuring compliance for regulatory documents. Set up, populates, and accurately maintains information using tools (e.g., CTMS such as IMPACT, SharePoint, etc.) and support systems; Manage and contribute to coordination and tracking of study materials and equipment; Coordinate administrative tasks during the study process, audits, and regulatory inspections, according to company policies and SOPs; Interface with the Data Management Center and/or Data Management Enablement representatives to facilitate the delivery of study-related documents and materials. Skills: ETMF, ISF, CTMS, IMPACT, SharePoint & ANGEL. Must be willing to travel and/or relocate to work in various worksites throughout the US. No telecommuting. Send resume to Truminds Technologies Inc, 5899 Preston Rd, Suite 501, Frisco, Texas 75034.

REQUIREMENTS: Master’s degree in Pharmaceutical Sciences, Statistics with 2 years of experience in a job title with similar duties and skills.

SALARY: $108, 867.00/Year

HOURS: 40 hours/week, Mon- Fri, 9:00am – 5:00pm

JOB LOCATION: Truminds Technologies Inc. 5899 Preston Rd, Suite 501, Frisco, Texas 75034.

CONTACT: Jagdish Ambre / Operations and HR Manager Phone: 469-850-1383

TITLE: Senior SAS Programmer

DUTIES: Develop statistical programs in SAS to generate clinical datasets, tables, listings, and figures; Perform validation & QC of programs, datasets, and statistical reports per study requirements; Develop & review CDISC SDTM and ADaM mapping specifications; Ensure compliance of CDISC SDTM and ADaM datasets by running P21 validator & documenting issues; Generate & review submission documents such as define.xml, SDTM annotated CRF, and reviewers guide; Review study documents such as Protocol, CRF, & SAP; Perform CRF SDTM annotations & CDISC Controlled Terminology Management; Work with SAS Scalable performance Data Server to reduce extraction, transformation and loading times; Prepare SAS programming reviewers guide as per standards for submissions. Skills: SAS, CDISC SDTM, ADaM, P21 validator, .xml & SDTM. Must be willing to travel and/or relocate to work in various worksites throughout the US. No telecommuting. Send resume to Truminds Technologies Inc, 5899 Preston Rd, Suite 501, Frisco, Texas 75034.

REQUIREMENTS: Master’s degree in Management information Systems, MBA in Business Management with 1 year of experience in a job title with similar duties and skills.

SALARY: $107,869.00/Year

HOURS: 40 hours/week, Mon- Fri, 9:00am – 5:00pm

JOB LOCATION: Truminds Technologies Inc.5899 Preston Rd, Suite 501, Frisco, Texas 75034.

CONTACT: Jagdish Ambre / Operations and HR Manager, Phone: 469-850-1383

TITLE: Senior Clinical SAS Programmer

DUTIES: Extract & analyze data using different databases like Rave, Oracle, & MySQL; Create, test and modify computer systems, programs & integrations; Annotate CRF’s & review annotated CRF’s, create Specifications and review Specifications based on SDTM IG & ADaM IG; Involve in Development of SDTM datasets & ADaM datasets and validate SDTM & ADaM datasets as well; Generate different outputs like table’s, listings & Graphs as per requirements for both Safety and Efficacy; Use PROC SQL to perform queries, join data cleaning & listings; Create technical specifications & Validation Tracking & also responsible for design & development of integration module; Design XSL style sheets as per business requirements. Apply Software development life cycle (SDLC) principles in developing programs. Skills- Rave, Oracle, MySQL, SDTM IG, ADaM IG, PROC SQL & SDLC. Must be willing to travel and/or relocate to work in various worksites throughout the US. No telecommuting Send resume to Truminds Technologies Inc, 5899 Preston Rd, Suite 501, Frisco, Texas 75034.

REQUIREMENTS: Master’s degree in Computer Information Systems and Information Technology, Computer Science with 2 years of experience in a job title with similar duties and skills.

SALARY: $81, 286.00/Year

HOURS: 40 hours/week, Mon- Fri, 9:00am – 5:00pm

JOB LOCATION: Truminds Technologies Inc. 5899 Preston Rd, Suite 501, Frisco, Texas 75034.

CONTACT: Jagdish Ambre / Operations and HR Manager, Phone: 469-850-1383

TITLE: SENIOR STATISTICAL ANALYST

DUTIES: Provide statistical input while developing protocols and case report forms (CRFs), taking into account factors such trial design, sample size estimation, randomization, statistical methods for protocols, and data editing checks for clinical trials; Transform specifications into SAS code to produce datasets, Tables, Listings, and Figures outputs (TLF), and shells for interim analyses, preliminary reports, and Statistical Reports in accordance with the Statistical Analysis Plan (SAP); Establish Statistical Analysis Plans for Integrated Safety and Effectiveness (ISS/ISE);Create and verify datasets in accordance with CDISC (SDTM and ADaM) criteria; Develop generalized utility macros to automate programs for standard reports and validations; Create SAS datasets using CDISC Study Data Tabulation Model (SDTM) /ADaM Implementation guide for Statistical summaries and Analysis. Skills- CDISC, SAP, SDTM and ADaM, ISS/ISE & SAS Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting. Send resume to Truminds Technologies Inc, 5899 Preston Rd, Suite 501, Frisco, Texas 75034.

REQUIREMENTS: Master’s degree in Public Health, Health Administration with 2 years of experience in a job title with similar duties and skills.

SALARY: $81, 286.00/Year

HOURS: 40 hours/week, Mon- Fri, 9:00am – 5:00pm

JOB LOCATION: Truminds Technologies Inc. 5899 Preston Rd, Suite 501, Frisco, Texas 75034.

CONTACT: Jagdish Ambre / Operations and HR Manager, Phone: 469-850-1383

Perform statistical analysis by using Proc Print, Proc Means, Proc Freq & Proc Report; Import raw data & create SAS data sets from flat files of formats like delimited, CSV and XPT; Generate datasets from raw sets files using Import Techniques & modify datasets using Set, Merge, Sort, Update, Formats, & Functions; Experience in SAS/BASE, SAS/MACROS, SAS/EG & SAS/ACCESS; Perform Statistical analysis by Proc Gplot, Proc Mixed & Proc Lifetest; Write SQL queries & stored procedures leveraging SQL Passthrough, Hash lookups and format lookups; Develop SAS macros, templates & utilities for data cleaning and reporting; Provide programming input to CRF, SAP, Analysis file specifications, Tables, figures, & listings (TLF) shells; Use SAS/ODS to generate XML, RTF, MS Excel, PDF, & HTML.

Skills: PROC PRINT, PROC MEANS, PROC FREQ, PROC REPORT, SAS/BASE, SAS/MACROS, SAS/EG, SAS/ACCESS, PROC GPLOT, PROC MIXED, PROC LIFETEST, SQL QUERIES, SAP, SAS/ODS, XML & RTF.

Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Clinical Data Manger is Responsible for collecting data from clinical trials created for pharmaceuticals, biologics, or devices. Ensures data collected is accurate, groups data properly, solves operational problems, and prepares statistical reports. Work with complex computerized records systems and maintain security and integrity. Collect data from clinical trials. Sort information and then ensure it’s screened, grouped, summarized, transcribed, coded. Consult with other employees to solve operational or data problems. Provide clerical duties such as data entry, transcription, coding, and collating searches. Prioritize work in line with project management decisions. Manage clinical trials through review, computerization, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines and regulatory agency guidelines. Validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines. Generate data retrievals and summaries. Query data inconsistencies and revise case report forms in compliance with standard operating procedures. Review case report forms for completeness and consistency. Implement strategy for data cleaning and the design and programming of clinical databases. Review and approve design, data review ground rules and database design according to Standard Operating procedures and protocol.

Skills: Database/coding/computer skills, Report writing Analytical, EDC, SAS, and CDISC.

Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Validation engineer is Responsible for performing validation of computer systems, process automation, equipment, utility systems, and/or facilities by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements including GAMP5. Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages. Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements. May also investigate and trouble-shoot problems which occur and determine solutions. Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. Maintains all documentation pertaining to validation. Will assist in developing procedures and/or protocols. Coordinates contract personnel through completion of assignments. Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups as required. May provide day-to-day guidance and training to other validation technicians. Serves as an information resource to validation technicians, contractors and vendors. Resolves validation issues of moderate scope with limited direct supervision. Understanding and application of validation principles, concepts, practices, and standards. Working knowledge of current Good Manufacturing Practices (GMPs). Previous experience with Computer System Validation (CSV) and experience with System Development Life Cycle of automated computer systems within biopharmaceutical environments. Working knowledge of validation of process control (PCS) and data acquisition systems is preferred.

Skills: Proficient with Microsoft Office Suite or related software.

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Clinical data analysts have a wide variety of responsibilities to fulfill. Responsibilities include validating results and conclusions from experiments and data from research for use in clinical business intelligence systems; overseeing external and internal data management activities; and expanding or modifying the system to serve new purposes and improve workflow. They are also responsible for training the staff to work with different computer systems and programs, developing programs to collect and record data accurately, and design and test data collection systems. Also, analyze future and current end-user requirements to improve clinical operations; design clinical and administrative reports; develop and analyze systems for obtaining statistics from research projects; and create mechanisms for approving and distributing information. This role is also involved in reviewing, extracting, compiling, and analyzing patient data such as coded financial and medical records. Clinical data analysts may also provide on-the-job training, undertake quality improvement initiatives, and give departmental orientations. They may be skilled in other clinical data management software. Knowing how to analyze data must keep all medical, financial, and legal information confidential.

Skills: Microsoft Office software such as Word, Excel, PowerPoint, and Access.

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Drug safety associates are responsible for ensuring that drugs and other pharmaceutical products are safe to use. They commonly work in a laboratory setting, testing new drugs or reviewing existing ones to ensure that they meet quality standards. Drug safety associates may also be tasked with monitoring the effects of certain drugs on human subjects. This can include observing patients who are taking these drugs as part of clinical trials or performing tests on animals to determine how different substances interact with each other. Also, they are responsible in reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug. Conducting site visits to observe the distribution process to ensure compliance with federal regulations. Performing clinical research studies involving human subjects in accordance with appropriate standards of ethics and safety. Monitoring compliance with drug licensing laws and regulations. Ensuring the safe handling of pharmaceuticals by maintaining proper storage conditions. Preparing reports about the status of drug inventories and other pertinent information to management. Suggesting methods to improve workflow processes within the pharmacy department. Administering medications to individuals according to established protocols. Providing assistance in the investigation of medication errors or problems with drug labeling or packaging

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Regulatory Affairs Associate, independently prepares, reviews without appreciable direction and submits high quality, regulatory submissions such as ANDAs to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.

Compile and complete high quality ANDAs and Amendments ensuring final submission meet requirements of ANDA checklist recommended by USFSDA to avoid any acceptance to file issues. Ensure all submissions and projects are completed with the expected timeline. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Provides guidance and direction to junior employees

Coordinates with external vendors for project support activities. This may include but not limited to: RS statements, TSE/BSE statements, Melamine free certificates, cGMP certificates, Debarment certificates, US agent letters, DMF Loa’s, Technical data sheets and technical drawings, Quantitative compositions of colors, flavors etc., Follow up with purchase team for DMFs and compliance to DMF review comments. Organize and maintain submission components associated with a regulatory submission electronically. This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress etc. independently. Reviews ANDAs against Refuse-to-Receive (RTR) Standards Guidance to prevent deficiencies that could result in RTR’s from the FDA – review includes a critical detailed assessment that technical documentation and information is available, accurate and complete for submission. Provides guidance and direction to junior employees for screening of ANDA’s against the checklist. Represents regulatory affairs in project team meetings and provides regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues. Prepare and update the road map for each assigned product with committed timeliness by each department. Evaluate change controls and formulates strategies for correct filing categories, with guidance from manager. Proactively raises major project issues if any to manager for resolution and agreement. Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time.

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Clinical Trials Associate (CTA) is involved in the conduct of the study and interfaces with the Study Manager and the Study Team. The CTA also supports the Study Team by creating and distributing study team materials, tools and documents. Creating and or reviewing study plans, specification documents, materials and tools. Ability to communicate clearly both verbally and written to sites, vendors, CROs, internal study team, etc. Track study progress in CTMS including patient enrollment and patient status, Oversight of Regulatory documents for site initiation. Provide access to systems when applicable. Track and ensure training of study team. QC oversight of CRO, TMF, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines. Process and track payments to vendors and study sites as appropriate. Oversee TMF Quality Review for study team, complete TMF QC for department on a quarterly basis for each study Collecting, quality review and submitting documents to the TMF. Performing QC of TMF as appropriate. Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors. Generate, finalize and distribute study team agendas and meeting minutes. Assist with generating the CSR appendices and participate in SOP and WP development. Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives.

Skills: Computer skills – MS office suite CTMS (TW, Celtrak), Familiarity with ICH / GCP and regulatory guidelines/directives.

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Clinical Research Associates should assist in organizing and monitoring the different stages of clinical trials. The following are other duties and responsibilities a Clinical Research Associate should be able to execute. Supervise study sites and activities to ensure adherence to appropriate industry protocols and terms of the study. Collect and authenticate data collection forms otherwise known as case report forms. Screen potential study participants through medical record reviews, interviews and follow-ups with healthcare providers. Coordinate with ethics committees to safeguard the rights, safety and wellbeing of all research subjects and research activities. Maintain specific records of research activity to include regulatory forms, drug dispensation records, case reports and consent forms. Prepare final reports, occasional manuscripts or publication, New Drug Applications (NDAs) and Biological License Applications (BLAs). Ensure proper transmission of clinical case data to the data management centers, review case reports questions and problems and clarify or obtain alterations to data as appropriate. Oversee research, technical and administrative staff, to include training, hiring, goal setting and distribution of workload.

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Medical Coder, or Certified Professional Coder, is responsible for reviewing a patient’s medical records after a visit and translating the information into codes that insurers use to process claims from patients. Accounts for coding and abstracting of patient encounters, including diagnostic and procedural information, significant reportable elements, and complications. Researches and analyzes data needs for reimbursement. Analyzes medical records and identifies documentation deficiencies. Serves as resource and subject matter expert to other coding staff. Reviews and verifies documentation supports diagnoses, procedures and treatment results. Identifies diagnostic and procedural information. Audits clinical documentation and coded data to validate documentation supports services rendered for reimbursement and reporting purposes. Assigns codes for reimbursements, research and compliance with regulatory requirements utilizing guidelines. Follows coding conventions. Serves as coding consultant to care providers. Identifies discrepancies, potential quality of care, and billing issues. Researches, analyzes, recommends, and facilitates plan of action to correct discrepancies and prevent future coding errors. Identifies reportable elements, complications, and other procedures. Serves as resource and subject matter expert to other coding staff. Assists lead or supervisor in orienting, training, and mentoring staff. Provides ongoing training to staff as needed. Handles special projects as requested.

Skills: Administrative writing skills, Reporting skills, Organizational skills, Record-keeping, Microsoft Office skills, Professionalism, confidentiality, and organization, Typing, Verbal Communication.

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]

The Application Developer should be responsible in Developing software solutions to meet customer needs. Creating and implementing the source code of new applications. Testing source code and debugging code. Evaluating existing applications and performing updates and modifications. Developing technical handbooks to represent the design and code of new applications. Work collaboratively with team to receive and respond to project requests. Research potential programming needs and required programming languages. Provide programming experience to creatively design software. Utilize industry-accepted testing methods troubleshoot flaws. Work with different teams and departments to ensure code quality. Create reports and present development updates to teams and stakeholders. Customize existing code to ensure efficiency and functionality. Accurately document programming and code changes.

Bachelor’s/Master’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc. Healthcare or technology related field.

REQUIREMENT: Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. No Telecommuting and Send resume to [email protected]