Reports to: Manager, Biopharmaceutics

Associate, Pharmacokinetics will apply his expertise in pharmacology and pharmacokinetics and knowledge of regulatory requirements to design Phase I/II clinical studies, provide scientific support during studies conduct, evaluate the study results and take part in preparation of clinical study reports. Associate, Pharmacokinetics will also provide scientific support for study teams in the areas of pharmacology, pharmacokinetics and regulatory guidelines for clinical trials conduct and will be an important contributor to the enhancement of scientific foundation of the company.

• Performs literature and data evaluation to provide scientific background for clinical studies design
• Prepares the PK portion of synopses for clinical studies
• Answers inquiries in process of preparation and reviews study protocols
• Performs/reviews pharmacokinetic analysis of concentration-time data
• Prepares/reviews the pharmacokinetic section of study reports
• Interacts and provides input and feedback to Biostatistics Department for data analysis
• Reviews statistical output to evaluate study results
• Reviews study reports
• Provides scientific support to other departments and teams in the areas of pharmacology, pharmaceutics and pharmacokinetics
• Takes part in revision of the Biopharmaceutics Department and the company SOPs; provides input into departmental practices and maintains updated the study- and report-related templates
• Maintains the Biopharmaceutics Department databases; provides the department and the company with updated scientific literature and maintains regulatory guidelines updated

• M.Sc. in Pharmacy/Pharmacology or related field or B.Sc. Pharmacy/Pharmacology plus minimum 2 year experience with clinical trials design/data analysis
• Expertise in the fields of pharmacology and pharmacokinetics
• Proven abilities in literature evaluation, scientific and medical writing and scientific support
• Demonstrated analytical thinking with strong attention to detail
• Good organizational skills and ability for multitasking and prioritization

Send your resume via E-mail: vselitser@biopharmaservices.ca or

Fax: 416-747-8480

• To perform any technical and administrative functions as education & training allows; including any medication administration as required by the protocol and in accordance with implemented procedures, SOP’s, GLP, GCP regulations and the all-regulatory bodies.
• To conduct the Inform Consent process and ongoing communication of study information to subjects.
• To ensure subjects are efficiently monitored and that safety requirements or actions are implemented as necessary.
• To report every adverse event, irregularity or non-compliance that occurs during the study.
• To ensure that all documentation is accurate.
• To ensure liaisons with physicians as necessary.
• To assist on training as assigned. To perform any other study related tasks as required or any additional duties as professional qualifications and training allows

• Education: RN with current registration with regulatory body in Ontario.
• Current BCLS &First Aid certification, ACLS & GCP an asset.
• Acute care experiences an asset.
• 2-3 years experience in CRO environment (preferably in conduct of Phase I/Bioequivalence studies)
• Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
• Ability to accommodate a flexible work schedule
• Evening/Weekend availability required

Send your resume via E-mail: ekatsoulis@biopharmaservices.ca or

Fax: 416-747-8480

• Conduct of procedures according to Protocol the applicable Good Clinical Practice (GCP) guidelines, applicable regulations and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times.
• Obtaining blood/Urine samples, obtaining ECGs, obtaining vital signs, performing a subject interview, processing of blood/Urine samples for shipment to the appropriate clinical diagnostic laboratory, obtaining subject’s Height, Weight and Frame size. Setting up the clinic according to the study requirements.
• Provide support as required, including but not limited to labeling of the specimen containers, copying, numbering, binding and archival of project and supporting documentation
• Conducting pre-shipment sample inventories and preparing sample shipments
• Other duties as may be required & as training and experience allow

• 2 year Medical Technology Diploma, or equivalent
• 1-2 years work experience in a CRO (preferably in conducting Phase I /Bioequivalence clinical trials)
• 1-2 years of recent phlebotomy and ECG experience
• A minimum of 1 year of experience in a basic laboratory setting
• Flexible hours depending on business requirements.
• Rotating shifts and weekend requirements.

The Biostatistician will be responsible for all matters relating to planning, preparation, review and interpretation of data for clinical studies for regulatory submissions, and providing both leadership skills as well as technical expertise to the project teams. The incumbent will participate in developing clinical trial protocols, write Statistical Analysis Plans, perform statistical analyses, and generate Statistical and Clinical Study Reports.

• Develop SAS codes to create accurate, complete and efficient statistical analysis datasets; and to generate statistical analysis output tables, listings and graphs.
• Strong ability to develop SAS® programs; knowledge of applications and interpretation of SAS® procedures.
• Solid understanding of clinical drug development process and knowledge of FDA regulatory requirements and ICH/GCP guidelines is preferred.
• In-depth knowledge of regulatory requirements in clinical studies
• Conduct all work in compliance with Standard Operating Procedures (SOP’s) and to observe all FDA guidelines.

• A university degree BSc, M.Sc or Ph.D. in Statistics with SAS programming experience is required.
• At least 2 years of clinical experience in biostatistics or 5 years of experience in the pharmaceutical industry.
• Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
• Good interpersonal skills, good communication skills.
• Attentive to details, good initiative and able to work with changing priorities.

Reports to: Director, Project Management

• Manage Phase I/BE program and all other activities associated with our services
• Maintain a tracking process for the studies managed; including initiation, tracking, timelines reporting, budgeting and report writing
• Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to in all projects managed under your responsibility
• Within scope of position, provide sound scientific advice to clients either directly or via other BPSI staff; co-ordinate teleconferences with appropriate personnel, address client questions, concerns or comments
• Negotiate client’s milestones and assist staff as required
• Use appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Director, Project Management and/or Operations
• Actively participate in the weekly tracking meeting making sure you are current with the most current information from operations and provide any new client information
• Create and develop quotations for review by DPM and receive appropriate signatures as required
• Follow up with existing accounts on new business opportunities and manage activities around outstanding quotations, Confidentiality Agreements, Contracts etc.
• Whenever appropriate, maintain awareness and provide input on study designs and protocols
• Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)
• Ensure appropriate documents have been reviewed and circulated within BPSI prior to providing to clients
• If required, assist in promotion of BPSI at industry meetings and trade shows
• Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
• Assist finance department in developing transfer of pertinent financial information

• Bachelor of Science (B.Sc.) degree or equivalent
• Relevant background in the healthcare, pharmaceutical industry
• Minimum of 2 years experience in a project management role in either Phase I/BE or Phase I - IV setting
• Familiarity with the management of all phase I/BE
• Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
• Excellent interpersonal, communication and presentation skills
• Strong organization, prioritization and problem solving skills
• Ability to manage and handle several projects simultaneously
• Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)

Reports To: Recruitment Coordinator

• Ensure compliance with appropriate BioPharma Services Inc. SOP’s and GCP and ICH guidelines
• Ensure Supervisor, Recruiting and Medical Screening a complete study subject panel
• Chair a study protocol meeting with all the screening team
• Review protocol and eligibility inclusion/exclusion criteria
• Assist and/or perform performance evaluation
• Resolve volunteer and subordinates’ issues in professional and understanding manner.
• Assist and/or perform staff daily task schedule
• Coordinate and/or Conduct telephone eligibility screening of potential English speaking volunteers for inclusion or exclusion in all phases of clinical trials which includes but is not limited to:
  • Reviewing screening criteria,
  • Providing an overview of the study,
  • Responding to volunteer preliminary questions,
  • Capturing brief medical and medication history of volunteers
  • Completion of required paperwork
• Coordinate and/or book appointments for potential volunteers for onsite screening and assign volunteers to studies based on the results of medical screening visits
• Build and maintain solid relationships with all volunteers and Clinical Recruiting Representative by providing superior services.
• Monitor and/or perform daily data entry, maintenance and updating of electronic volunteer files into Bio Pharma Services Inc. CESR database for telephone recruitment
• Track statistics for clinical trials including but not limited to fill ratio, advertisement responses, and volunteer no show rates
• Involvement in departmental meetings
• Response with the Quality Assurance (QA) group study reports in timely manner.
• Work with the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures as required
• Other duties as may be required & as training and experience allow

• B.Sc. or equivalent education
• Completion of recognized Phlebotomy program/course
• 1 - 2 years experience in a customer service environment
• Strong organizing and planning skills to work independently with efficiency and accuracy
• A proven track record of customer service success
• Excellent interpersonal and public relation skills
• Requires tact and discretion in dealing with and handling confidential information
• Demonstrated proficiency in English, with excellent oral and written communications skills
• Decisive, good decision making skills, able to escalate response to situations when relevant
• Proficient in Microsoft Word, Microsoft Excel and Lotus Notes

Send your resume via E-mail: lyeghikyan@biopharmaservices.ca or

Fax: 416-747-8480

This position will be responsible for analyst the clinical data of clinical studies following the protocol and the statistical analysis plan, and generate Statistical and Clinical Study Reports.

• Develop and validate SAS codes to analysis clinical study data, generate output tables, listings and graphs in according to the study protocol and the statistical analysis plan
• Develop and validate SAS codes to perform data management tasks such as logic checks, data query, data cleaning, data listing and data export
• Perform statistical analysis on clinical study data, drug safety data, and write statistical reports
• Assist in creating and CRF and data management plans (DMP)
• Create randomization scheme for clinical studies
• Write and update SOPs
• Perform other miscellaneous activities as required

• A university degree BSc, M.Sc in Statistics with SAS programming experience is required.
• Solid understanding of clinical drug development process and knowledge of FDA and other regulatory requirements and ICH/GCP guidelines.
• In-depth knowledge of regulatory requirements in clinical studies
• At least 2 years of SAS programming experience in the pharmaceutical industry.
• Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
• Good interpersonal skills, good communication skills.
• Attentive to details, good initiative and able to work with changing priorities.
• Possesses an excellent understanding of the clinical data management process

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

This position leads the clinical data management process for the clinical trials and supervises the data entry team.

• Supervise and train the data entry team
• Develop study specific database for mainly Phase I studies and potentially for Phase II‑IV clinical studies
• Design and review CRF according to the study protocol
• Write and review Data Management Plans and other key study documents
• Create, review, and process Data Clarification Forms and updates the databases
• Lead the clinical data management process for clinical studies
• Develop Data Management SOPs and  training other staffs
• Perform other miscellaneous activities as required

Qualification & Experience:

• B.A./B.S. Degree in a related field or an appropriate combination of relevant education and experience.
• A minimum of 3 years clinical data management related experience
• Experience in developing CRF and setting up database
• Awareness of applicable regulatory rules and guidelines: e.g. ICH, GCP, GDP etc.
• Possesses excellent interpersonal and communication skills (written and verbal).
• Good project management and organizational skills
• Proficient in relevant computer software
• Possesses an excellent understanding of the clinical data management process

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

Reports to: Director, Biopharmaceutics

Manages and coordinate data management and statistics analysis activities and resources for clinical research, in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs).

• Over look the data management and statistical analysis aspects within BPSI for clinical studies
• Manage and coordinate the activities of the biostatistics team and data management team to meet corporate goals and objectives
• Develop project and department standards to ensure consistency
• Collaborate with management across functional areas to set priorities and timelines
• Provide expert critical review of clinical trial protocols to ensure alignment with project objectives
• Monitor data quality during study conduct for BA/BE and Phase I-IIa studies
• Provide advice on study design including identification of clinical endpoints and sample size estimation
• Provide expertise on regulatory guidance and requirements for the collection, analysis, and presentation of clinical data
• Provide expert critical review to clinical study reports, integrated summary documents and publications
• Represent BioPharma Services before regulatory bodies and the sponsors
• Responsible for the data quality and the accuracy of the statistical result
• Develop statistics analysis and data management strategy for clinical studies
• Contribute expert statistical input on regulatory questions
• Perform statistical analysis, determine the precise conclusions, write statistical reports and/or prepare data presentations for clinical registration
• Ensure data management plan (DMP) statistical analysis plans (SAPs) are in line with project objectives and consistent with project standards
• Participate in planning resource and budget needs
• Write/review SOPs relative to Biostatistics and Data Management

Qualification & Experience:

• M.Sc. in biostatistics and 5+ years clinical research experience in pharmamaceutical industry or CRO
• 3+ years of lead biostatistics experience
• 3+ years data management experience
• In-depth knowledge of pharmaceutical clinical development and ability to apply technical principles, theories and concepts to clinical drug development
• Understand regulatory drug submissions and approval process at the regional level
• Understanding of data management, statistics, pharmacokinetics,  protocol development, and report writing concepts and techniques of clinical trial principles
• Thorough knowledge of SAS procedures and clinical data processing with emphasis on regulatory agency requirements for data reporting
• Extensive knowledge of FDA/ICH regulations/guidelines
• Previous interaction with regulatory agencies on data management, statistics, and medical writing issues
• Excellent written and verbal communication skills and interpersonal skills

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

Reports to: Director, Biopharmaceutics

• Write Phase 1 and Bioequivalence study protocols, Informed Consent Forms, and clinical study reports.
• Interact with the Institutional Review Boards with respect to clinical study protocols, Informed Consent Forms and other documents as required.  Act as secondary liaison between the company and the Institutional Review Board.
• Assist in development of document templates, relevant SOPs and guidelines.
• Working closely with the clinical personnel and Principal Investigator to ensure that clinical documents are produced to the standard required by GCP.
• Conduct all work in compliance with Standard Operating Procedures (SOP’s), Good Clinical Practices (GCP) and to observe all regulatory guidelines
• Perform other work as assigned.

Qualification & Experience:

• Minimum university degree, B.Sc. (i.e. Life Sciences) or least 4 years of pharmaceutical, or clinical experience.
• Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
• Good interpersonal skills, good communication skills.
• Attentive to details, good initiative and able to work with changing priorities.

Send your resume via E-mail: jhe@biopharmaservices.ca or

Fax: 416-747-8480

Reports to: QC Data Review Supervisor

Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and Regulatory requirements.

Duties and Responsibilities:

• Review study files after completion and ensure that they are accurate and legible according to Protocol , SOPs and Regulations
• Ensure all prepared study source documents and/or Forms are in accordance to protocols SOPs and Regulations
• Review all other study related documentation: medical screening files, pharmacy labels and pharmacy files.
• Observe clinical procedures during the conduct of studies.
• Provide reports of the reviewed data to relevant  personnel/department
• Perform other duties as assigned by supervisor

Qualifications:

• College diploma in Science or relevant experience
• Knowledge of ICH, GCP
• Professional experience working in CRO
• Excellent communication skills
• Excellent computer skills

Send your resume via E-mail: lyeghikyan@biopharmaservices.ca or

Fax:416-747-8480

Reports to: Manager, Clinical Operations

To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.

• To perform any technical and administrative functions as education & training allows; including any medication administration under physician’s directions as required by the protocol and in accordance with implemented procedures, SOP’s, GCP regulations and regulatory bodies
• To conduct the Inform Consent process and ongoing communication of study information to subjects.
• To ensure subjects are efficiently monitored and that safety requirements or actions are implemented as necessary.
• To report adverse events, irregularity or non-compliance that occurs during the study.
• To ensure that all documentation is accurate.
• To liaise with the Principal Investigator and/or physician as necessary.
• To assist on training as assigned.
• To perform any other study related tasks as required or any additional duties as professional qualifications and training allows.

Qualification & Experience:

• Education: Foreign doctor
• Current BCLS & First Aid certification.
• Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
• Ability to accommodate a flexible work schedule

Send your resume via E-mail: ekatsoulis@biopharmaservices.ca or

Fax: 416-747-8480