Vacant Positions at Thermo Fisher Scientific

Essential Functions:   

Global supply management for assigned studies that include: 

• Supply forecasting, packaging and labeling 
• Global supply budget tracking and reporting 
• Consults clients on their supply chain requests 
• Preparation of the Clinical Supplies project Plan 
• Coordination, Maintenance, and Tracking of Drug Shipments and Returns 
• Third Party Vendor Management

Qualifications - External

Education and Experience:   

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification  
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience. Familiar with cGMP, GCP, GDP, and ICH knowledge and experience essential 
• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. 

Knowledge, Skills and Abilities:   

• Understanding of drug formulation, analytical method development, stability, and bulk drug manufacturing practices  
• Strong knowledge of the complete clinical supplies life cycle  
• Skilled in client and 3rd party relationship management  
• Very strong communication skills both written and verbal.  
• Excellent interpersonal skills and problem solving/decision making skills.  
• Demonstrate effective leadership and team building skills.  
• Strong computer skills: working knowledge of Microsoft Project, Excel, and Microsoft Word is required.  
• Strong organizational skills required.  
• Strong multi-tasking skills required.  

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Your responsibilities will include (but are not limited to) the following:

• Act as programming lead on Phase II-IV group of studies.
• As programming lead assume leadership responsibility as a contributing member of a global project team, communicating actively and frequently with other team members and ensuring adherence to working practice documents and SOPs.
• Provides input into bidding process as requested.
• May provide general infrastructure support to the Department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials etc.
• Provides training, guidance, and project leadership to junior team members. - Develop instructional training and education materials for the wider B&P community.
• Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF)
• Analysing and combining data from a variety of sources and structures including virtual trials, wearables, eCOA, etc.
• Generating visualizations (Spotfire), Statistical safety reports (TLFs), safety event notifications and data alerts for study teams.
• Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.

To be considered for the role you should have the following qualifications and experience:

• Master's degree in computer science, statistics, biostatistics, mathematics, or related field and at least 4 years of experience that provides the knowledge, skills, and abilities to perform the job requirements,

OR

• Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent formal academic / vocational qualification, and at least 6 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge/Skills:

• In-depth understanding of one or more programming languages
• Strong attention to detail
• Strong problem solving and innovative skills
• Strong written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines
• Capable of adapting and adjusting to changing priorities
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Demonstrated leadership, initiative, and motivation
• In-depth understanding of relational data base structure and complex data systems
• Capable of training and mentoring others
• Demonstrated leadership ability and ability to work on a multi-disciplinary project team
• Solid project management skills to act as project lead across the most challenging and complex projects
• Capable of effectively capturing biostatistical metrics
• Capable of providing quality control review for statistical programming and identifying solutions and process improvements.

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Essential Functions:

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations.
• Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
• Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan.
• Assures department adherence to good scientific, ethical, and regulatory standards.
• Reviews and ensures adherence to departmental working practice documents and SOPs, and contributes to their development.
• Increases knowledge base and professional skills of staff in areas including programming technology and techniques, clinical trials, and the pharmaceutical industry through on the job training, mentoring, and internal or external training courses.
• Works to increase the visibility of the company by encouraging the publications of articles in industry journals and presentations at conferences.
• Monitors and ensures adherence to contractual obligations or limits with our clients.
• Works directly with project team leaders and client representatives to assess and develop project goals and timelines.
• May serve in a project lead role on selected multiple projects.
• Provides general infrastructure support to the department. Examples include giving presentations at department meetings, contributing to documents or policies, contributing to and/or leading process improvement initiatives, and assisting with departmental web page development.

Education and Experience:

• Master's degree in computer science, statistics, biostatistics, mathematics or related field and at least 6 years of clinical trial experience.
• At least 2 years of leadership experience.

Or

• Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification, and at least 8 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.

Knowledge, Skills and Abilities:

• Advanced SAS programming skills and understanding of database structures.
• Solid management skills, including developing staff and their career objectives and the ability to motivate and inspire staff.
• Capable of effectively organizing and managing multiple staff and assignments.
• Advanced understanding of clinical trials.
• Capable of facilitating communication with clients, project teams, departments and staff.
• Solid decision making skills to decide company policies and procedures regarding programming.
• Solid understanding of tracking project budgets.
• Understand and participate in bidding programming work.
• Effective written and verbal communications skills, including proficiency in the English language.

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Key Accountabilities/Responsibilities:

• The Principal Biostatistician is responsible for all clinical aspects for the assigned global clinical studies from preparation until archiving.

The study responsibilities include:

• Serves as the responsible biostatistician on Phase I to III clinical trials, ranging from relatively simple or complex.
• Contributes to clinical study synopses and protocols.
• Develops statistical analysis plans and/or performs senior review of statistical analysis plans.
• Reviews statistical analyses of other statisticians and interprets results from simple to complex clinical studies.
• Provides relevant input in the development and review of CRFs.
• Performs lead review and sets up internal QC of TFLs.
• Performs critical review of derived datasets specifications and derived datasets (ADaM).
• Contributes to clinical study reports.
• Reviews simple to complex randomization specifications and dummy randomization schemes.
• Participates in bid defense meetings.
• Oversight of project financials.
• Participates in meetings with diverse regulatory authorities (FDA, EMA, PEI).
• Contributes to press releases and scientific papers.

Skills and Experience:

• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience, plus lead statistician experience.
• Experience in handling CROs and vendors.
• Experience with Data Monitoring Committees (DMC's)
• Exhibits expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Proficient with other statistical software such as R, EAST, Winbugs is a plus.
• Detailed knowledge of and experience with CDISC standards is desired.
• Demonstrates ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Displays excellent communication skills with proven leadership ability.
• Knowledge of ICH-GCP and other applicable legislation to successfully implement the clinical study.

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Job Description

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational products through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports tothe Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.

Job Complexity

• Works on problems of limited scope.
• Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

Job Knowledge

• Learns to use professional concepts.
• Applies company policies and procedures to resolve routine issues.
• Supervision Received Normally receives detailed instructions on all work.
• Business Relationships Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.
   

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Job Description

• Replacement CRA, Based in JHB, able to start ASAP

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Essential Functions:

• Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.

General Support:

• Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to CRG’s corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as
• requested.
• Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
• Contributes to departmental process improvement initiatives.

Clinical Trial Support:

• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
• Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
• Provides medical review of adverse events of special interest, serious adverse
• events and clinical outcomes events reported by study sites.
• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Marketed Products Support:

• Manages signal detection activities, generates aggregate reports, contributes to label updates, 
• supports dossier maintenance and risk management activities.
• Medically reviews adverse event and serious adverse event data from all sources(solicited, spontaneous, literature, etc.) as contracted.

Job Complexity:

• Develops solutions to highly complex and unique issues that impact and address future concepts, products or technologies.

Job Knowledge:

• Having broad expertise or unique knowledge in Pediatrics or Internal Medicine with Infectious Disease and/or Rare Disease experience.

Education and Experience:

• MD or equivalent required. Active medical licensure preferred.

Knowledge, Skills and Abilities:

• Therapeutic expertise across one or more medical speciality or sub-specialities
• Strong decision-making, problem solving, organizational skills and analytical skills
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases (e.g. Medra)
• Flexibility to travel domestically and internationally
• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
• Proficiency in basic computer applications
• Fluent in spoken and written English
• Excellent interpersonal, influencing and team building skills
• Understanding guidelines (FDA, ICH, EMA and GCP)