Jobs at PAREXEL

About This Role

• Parexel are currently recruiting for a sponsor dedicated Senior Clinical Research Associate I (SCRA I)
• The SCRA I will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level.
• Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements.
• The SCRA I will collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready and will coordinate with institutions and investigators at the local level.

Some specifics about this advertised role

Oversight of Monitoring Responsibilities and Study Conduct

• Ensuring regulatory, ICH-GCP and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required.
• Demonstrates diligence in protecting the confidentiality of each subject and assesses factors that might affect subject safety and clinical data integrity at an investigator site such as protocol deviation and violations and pharmacovigilance issues.
• Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations.
• Conducts source document review and verification of appropriate site source documents and medical records.
• Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete.
• Manages reporting of protocol deviations and appropriate follow up.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• May perform Investigational Product (IP) inventory, reconciliation and reviews storage and security.
• Verifies the IP has been dispensed and administered to subjects according to the protocol and verifies issues or risks associated with blinded or randomized information related to IP.
• Applies knowledge of GCP and local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported, and released and returned.
• Manages reporting of identified issues and manages follow up to resolution.
• Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP.
• Ensures all activities are managed by site personnel who are appropriately delegated and trained.
• Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• For assigned activities, understands project scope, budgets, and timelines; manages site level activities and communication to ensure project objectives, deliverables and timelines are met.  (Must be able to quickly adapt to changing priorities to achieve goals and targets).
• Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks.
• Reviews site signature sheet and delegation of duties log to confirm any newly added or removed site staff are documented appropriately and the log is up to date.
• Where the site or Site Signature Sheet and Delegation of Duties Log indicates site personnel are no longer active on a study, review and assess training compliance with any new and updated training requirements (i.e., protocol amendment(s), etc.)
• Conducts follow up for escalated adverse event monitoring (AEM) report queries.
• Checks the site and external facilities, equipment, and supplies (clinical and non-clinical) continue to be adequate to conduct the trial and with their expiry dates (as applicable).
• Checks site specific logs are complete and up to date (e.g., Site Visit Log, Screening and Enrollment Log, Signature Sheet and Delegation of Duties Log, Subject Identification Code List, IP Accountability Log).

Collaboration

• Collaborates with primary Site Manager who will act as the primary liaison with site personnel.
• Prepares for and attends Investigator Meetings and sponsor face to face meetings.
• Participates in global clinical monitoring and project staff meetings (inclusive of client representation, as applicable) and attends clinic.

Who are Parexel?

• Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.
• We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.
• You’ll be an influential member of the wider team.

What we are looking for in this role

• For every role, we look for professionals who have the determination and courage always to put patient well-being first.
• That to us is working with heart.
• Here are a few requirements specific to this advertised role.

Skills

• Networking and relationship building skills.
• Ability to communicate effectively and appropriately with internal and external stakeholders.
• Ability to adapt to changing technologies and processes.
• Effectively overcoming barriers encountered during the implementation of new processes and systems.
• Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization.
• Identifies and builds effective relationships with investigator site staff and other stakeholders.
• Proficiency in local language is required.
• Advanced level or fluency in English is required.

Education

• Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.

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About This Role

• At Parexel FSP people make a difference.
• We have a crucial mission: to prevent and cure disease by delivering important new medicines and therapies to patients in need.
• We achieve this important goal through the knowledge, expertise, innovation, and commitment of our employees around the world.
• Parexel is currently seeking a Senior Statistical Programmer to join us in South Africa, dedicated to a single sponsor.

Picture Yourself At Parexel:

• The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, acts as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data.

What You'll Do At Parexel:

Project Management

• Ability to fill Statistical Programming Lead role on projects.
• Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
• Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.
• Monitor project resourcing, project budgets, and identify changes in scope.
• Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.
• Review statistical analysis plans and mock-shells.
• Review database set-up specifications.
• Interact with sponsors and internal stakeholders with regard to statistical programming issues.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work.

Statistical Programming for Assigned Projects

• Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM/TLF), tables, figures, and data listings.
• Produce/QC dataset specifications and other process supporting documents and submission documentation.
• Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.

Training

• Maintain and expand local and international regulatory knowledge within the clinical industry.
• Develop knowledge of SAS and processes/procedures within other Parexel functional areas.
• Provide relevant training and mentorship to staff and project teams.

General

• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
• Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.
• Proactively participate in and/or lead process/quality improvement initiatives.
• Represent Parexel at sponsor marketing and technical meetings.
• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Here are a few requirements specific to this advertised role:

• Proficiency in SAS.
• Proven clinical / statistical programming experience within pharmaceutical clinical development (@ least 3 years minimum).
• Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
• Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
• Demonstrated proficiency in analytical programming.
• Excellent analytical skills.
• Have in-depth understanding of clinical data structure (e.g., CDISC standards) and relational database.
• Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
• Demonstrated ability to work in a team environment with clinical team members.
• Strong project management skills.
• Good business awareness/business development skills (including financial awareness).
• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
• Competent in written and oral English.

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About this Role

• Parexel is currently seeking a Clinical Programmer to join us in South Africa, dedicated to a single sponsor.
• This role will be responsible for the provision of data review and trial management deliverables across all compounds and trials for which these are required, and for all functional groups that require those deliverables.
• Working as a Clinical Programmer at Parexel FSP offers tremendous long-term job security and prospects.
• We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50.
• And we have an incredible pipeline of work.
• Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Responsibilities

• Program simple to complex data review listings, exception reports, QTL/KRIs, metrics reports and visualizations in a fast-paced environment for clinical trial data review and management purposes.
• Liaise with Clinical Data Management and/or cross functional staff to understand the needs of the end users of the listings, reports, and metrics.
• Contribute to the development of software systems and related infrastructure to generate displays of clinical study data and metrics reports that are efficient and user-friendly.
• Create and document archives of software and deliverables.
• Create any Work Instructions process and training documents needed related to clinical programming and the required deliverables.
• Provide time and resource estimates for project planning as well as accurately record time spent on multiple deliverables.

Here are a few requirements specific to this advertised role.

• Bachelor’s degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields.
• Minimum of 5 years of experience in developing software in a clinical trial environment using SQL, including at least 3 years of clinical programming experience.
• Skilled in programming in a relational database setting with SQL and/or T-SQL or ETL.
• Experience with data reporting tools in a clinical trial setting.
• Experience in the Biotechnology, Pharmaceutical, or Life Sciences industries (Clinical Research Organization CRO or Clinical Trial regulated environment preferred).
• Experience with the eClinical Solutions elluminate platform a plus; experience with Qlik Sense a plus.
• Preferred additional external data transfer experience in:
• Creating external data transfer specifications, ensuring external clinical trial data are compatible with the clinical database to support data integration, analysis and reporting.
• Experience in planning, set-up, and acquisition of external clinical data at the study level
• Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.)
• Knowledge of some additional programming languages (e.g.: SAS, PL/SQL, R, Python, Java, …) a plus.
• Ability to balance and prioritize multiple assignments and respond quickly to ad hoc requests.
• Familiarity with CDISC standards, including CDASH and SDTM.
• Working knowledge of Microsoft products: Outlook, Word, Excel, Teams.
• Excellent verbal and written communication skills.
• Strong English language written and verbal communication skills.