Careers
Join our team! Seeking highly motivated, innovative thinking, medical and scientific professionals.
BioPharma Career Opportunities
Want to be inspired?
With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter. Everything we do – and we do it with passion – is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
Our BioPharma family is key to our success. We create an environment where the brightest minds have space to innovate. Where there are always new opportunities to learn and grow. Where you can feel at home. Our award-winning dynamic teams, specializing in the conduct of Phase 1/2a and Bioequivalence clinical trials, are at the forefront of medical research advances every day. Could this be the right place for you?
Diversity & Inclusion
BioPharma Services is committed to creating an inclusive workforce that encourages, supports and celebrates the diverse voices of our employees from any background. We believe diversity and inclusion drives innovation and makes our company stronger. Our objective is to hire great people and build a culture where difference is valued.
Currently Hiring for These Positions
Project Director
Position Summary:
Reporting to the Director of Project Management, the Project Director will provide integrated direction, management and leadership in the administrative and project planning, budgeting, and process improvement efforts of Phase I studies and Key Accounts impacting core functions and components across the organization.
Duties and Responsibilities:
- Directs and integrates the activities of multiple, major project operations; manages a diverse team of professional and support staff, both directly and through managers and/or supervisors.
- Participates and oversees the development, implementation, and maintenance of individual project objectives.
- Leads the development of processes and procedures for Phase I projects and its execution as directed by Director of Project Management.
- Working under the direction of the Director of Project Management champions change and effectively manages the implementation of new strategic ideas and key process improvement initiatives within department or across operational segments of Bio Pharma Services Inc.; achieves excellence in all areas of business.
- As needed or assigned, acts as a support/backup to Director of Project Management.
- Supports and solicits input from team member at all levels within the organization.
- Continuously defines ways to increase client satisfaction and deepen client relationship; ensures service delivers superior satisfaction to clients and provides senior level resolutions.
- Lends expertise to internal teams and enforces current policies and procedures.
- Grows long-term relationship with clients and capitalizes on potential opportunities.
- Provides leadership and guidance in all aspects of the project life cycle.
- Maintains a tracking process for the studies managed, including initiation, tracking, timelines reporting, budgeting and report writing.
- Within scope of position, provides sound scientific advice to clients either directly or via other BPSI staff; co-ordinates teleconferences with appropriate personnel, addresses client questions, concerns and/or comments.
- Negotiates client’s milestones and assist internal stakeholders as required.
- Uses 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 Management.
- Actively participates in the weekly tracking meeting to ensure project timelines are current with the most up-to date information from operations and to update operational team of any new information available from the client.
- Leads feasibility assessment of complex Phase I projects with key department stakeholders; provides support in the review and development of proposals on as-needed basis.
- Proactively recognizes any change in scope; collaboratively works with Contracts & Proposals team and Business Development to develop and ensure timely completion and issuance of change orders.
- Follows with existing accounts on new business opportunities and manage activities around outstanding proposals and contracts.
- Assists 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.
- Ensures appropriate documents have been reviewed and circulated within BPSI prior to providing to clients.
- If required, assists in promotion of BPSI at industry meetings and conferences.
- Maintains a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, NMPA, ANVISA) and understanding of basic pharmacokinetics and statistics.
- Coordinates client visits and follow up on requested documents from clients including, but not limited to, regulatory documents, study documents, validation report and brochures.
- Performs miscellaneous job-related duties and other task as assigned.
Qualifications:
- Bachelor of Science (B.Sc.) degree or equivalent; at least 5 years of experience directly related to the duties and responsibilities specified.
- Relevant background in the healthcare and/or pharmaceutical industry.
- Minimum of 5 years’ experience in a senior project management role in either Phase I or Phase II – IV setting.
- Excellent understanding of how studies are run and how they are managed.
- 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 organizational skills with the ability to adapt and adjust to changing priorities, apply and problem-solving skills.
- Demonstrated ability to independently manage multiple projects simultaneously.
- Highly proficient with Microsoft Office Suite (Word, Excel, PowerPoint, MS Project).
To Apply, please send an email to mlaughlin@biopharmaservices.com with your email subject line mentioning Project Director Role at BioPharma Services or fill in the form below.
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Clinical Data Manager
Position Summary:
The Clinical Data Manager is responsible for the set up and management of the clinical study database, the collection and quality of the clinical study data and the preparation of the clinical data to current regulatory and industry expectations and standards.
Duties and Responsibilities:
- Independently perform all activities related to data management per regulations and applicable standard operating procedures (SOPs)
- Provide guidance to junior members of the Data Management group
- Develop, test and lock study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
- Responsible for reviewing and contributing to protocols from a data management perspective
- Manages the process from DMP development to data entry, data cleaning and data transfer, data lock to data export
- Create Data Management Plans (DMP) and other data management documents for projects as required and manage the execution of all plans
- Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
- Creates data dictionary for data users
- Manages the medical coding process internally or through external vendors
- Develop, review and execute electronic data edit checks for web-based forms
- Perform Data Entry and Quality Control (QC) on study data and programs as needed
- Create, review, and process data queries and updates the databases
- Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
- Perform third party non-CRF data management activities, including data transfers and Serious Adverse Event (SAE) Reconciliation
- Works collaboratively with other Pharmacokinetics staff, Biostatisticians, cross-departmentally within BPSI to meet project deliverables and timelines for clinical statistical programming and reporting
- Efficient collaboration with the team from vendors to ensure timely deliverables with high quality
- Participates in and may lead process improvement activities within the department and cross functionally, including SOP development
- Coordinate with the immediate supervisor or Manager Data Management to track and report status and progress of data management activities for allocated trials and be proactive to ensure smooth, successful and timely locking of databases
- Serve as trainer/mentor for Data Management associates
- May coordinate with Lead Data Manager/Senior Data Manager to ensure that assigned trials are managed efficiently with high quality
- Other duties & responsibilities as required
Qualifications:
- At least 3 years of experience in Data Management, performing activities in setup, conduct and locking of clinical data
- BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
- In-depth understanding of database structures and database programming
- In-depth knowledge of CDISC standards, especially CDASH and SDTM
- In-depth knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
- Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
- Strong analytical and problem-solving skills
- Must have strong communication (both verbal and written), interpersonal, and client services skills, be highly organized and self-motivated
- Good organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail
- Ability to be flexible and adapt to change, to work independently, and take a leading and collaborative role in multi-disciplinary teams
To Apply, please send an email to mlaughlin@biopharmaservices.com with your email subject line mentioning Clinical Data Manager Role at BioPharma Services or fill in the form below.
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Clinical Data Specialist
Position Summary:
The Clinical Data Specialist, working with senior data management members, is responsible for the setup, documentation, implementation and locking of clinical study databases and clinical data for clinical studies to current regulatory and industry expectations and standards.
Duties and Responsibilities:
- Perform assigned activities related to data management per regulation and applicable standard operation procedures (SOPs)
- Contributes to the development, testing and locking of study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
- Involved in reviewing and contributing to protocols from a data management perspective
- Involved in the management of the process from DMP development to data entry, data cleaning and data transfer, data lock to data export
- Contributes to or writes the Data Management Plan (DMP) and other data management documentation
- Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
- Creates data dictionary for data users
- Manages the medical coding process internally or through external vendors
- Develop, review and execute electronic data edit checks for web-based forms
- Performs quality control (QC) on study data and programs as needed
- Create, review, and process data queries and updates the database
- Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
- Perform third party non-CRF data management activities, including data transfers and Serious Adverse Event (SAE) Reconciliation
- Works collaboratively with other Pharmacokinetics staff, Biostatisticians, cross-departmentally within BPSI to meet project deliverables and timelines for clinical statistical programming and reporting
- Performs data entry as required
- Other duties & responsibilities as required
Qualifications:
- Experience in data entry or Data Management activities, performing activities in relationship to setup, conduct and locking of clinical data
- BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
- Understanding of database structures and database programming
- Knowledge of CDISC standards, especially CDASH and SDTM
- Knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
- Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
- Strong analytical and problem solving skills
- The ability to multi-task and prioritize are essential
- Strong oral and written communication skills
- Self-motivated, with the ability to learn quickly and independently
To Apply, please send an email to mlaughlin@biopharmaservices.com with your email subject line mentioning Clinical Data Specialist Role at BioPharma Services or fill in the form below.
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What are early phase clinical trials?
Clinical Trials are divided into 4 phases. Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.
The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects. Phase 1 trials are conducted in healthy volunteers.
Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.
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What is a clinical trial?
A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective. In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.
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What is an investigational drug?
An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:
- If the drug is safe and effective.
- How the drug might be used in that disease.
- How much of the drug is needed.
- Information about the potential benefits and risks of taking the drug.
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Why do you need to take blood draws and how many blood draws will be required?
In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.
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Should I expect to experience any side-effects while doing studies?
As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.
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Will I be compensated for doing a clinical study?
Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).
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Are food and accommodation provided over the course of the trial?
Food – Clinical trials are conducted in a controlled setting which means that all food is provided and trial volunteers receive standardised meals. Individual meal plans or meal preferences cannot be provided. If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial. Please contact us to discuss any food issues.
Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender. Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.
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What is the length of a study and do I have to complete all the visits?
Details of the duration of a study can be found on the Volunteer Hub.
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What is informed consent and how is it carried out?
Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF). The ICF describes the clinical research study and the nature of the investigational product to be used, including:
- Your rights and responsibilities as a study participant.
- What you will be asked to do during study participation.
- The potential risks that you should be aware of.
During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff. You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.
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Can I bring my own device?
Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.
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What do I need to pack?
Wondering what to pack before your site visit? Visit our Packing List page to learn more.
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When do I receive compensation for taking part in a study?
You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)
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Where will I sleep during the clinical study?
We provide a clean, safe socially distance sleeping environment, in a dormitory of hotel room style. Watch video
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Can I bring my own food?
All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video
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Privacy
We respect and value the privacy of our volunteers. View our Privacy and Cookie Policy here.