Job Functions, Duties, Responsibilities and Position Qualifications:
Position Summary: The Project Manager is responsible for planning and implementation of project set up and ongoing protocol management supporting central laboratory services for phase I to phase III clinical trials. The project manager understands, supports, and prepares appropriate material and systems touching all operational aspects of laboratory delivery. The PM is responsible for timely communication with all levels of internal and external organizational personnel. PM liaises with pharma sponsors, clinical research organizations, and principal investigators and demonstrates a broad understanding of clinical trials life cycle as it relates to the central laboratory role.
Location: Austin, TX 78728 (100% onsite)
Duties & Responsibilities: - Review assigned protocols and amendments with a view to implement the study in accordance with client requirements.
- Liaise with sponsor clients to create Specification Documents (Scope of Work) including a communication plan and project plan tools (if required) for monitoring study progress.
- Facilitate the definition of study scope, goals and deliverables of the central laboratory.
- Review progress of studies and initiate appropriate actions to achieve target objectives.
- Ensure Systems team is provided with clear and accurate information for loading of static data into the database for readiness to define studies and build supplies for distribution to sites.
- Manage study budget ensure clients are provided updates on spend and whether scope creep or budget will be exceeded.
- Track and monitor study deliverables and communicate this to all stake holders (internal and external).
- As required by our clients, present reports defining study progress, problems and solutions.
- Work with Systems team to implement and manage study changes, modifications and interventions to achieve project outputs.
- Create training tools for presentations at Investigator Meetings and site training sessions.
- Prepare and present training at investigator meetings either in person or remotely.
- Provide regular updates to various department on study progress.
- Communicate risks to project deliverables in order to plan to mitigate risks.
- Liaise with Sponsor/CRO and Investigator Site personnel to ensure ongoing protocol compliance.
- Oversee data holds and maintenance of database ensuring clean data.
- Manage data handling requirements.
- Facilitate and coordinate study start-up meetings with internal stakeholders.
- Facilitate and complete study testing prior to migration in the production environment.
- Oversee and manage all communication activities with study sites, i.e. verbal & written: alerts, cancellations etc.
- IATA shipping of biological samples awareness and/or certification.
- Maintain GCP awareness and qualifications.
- Be available for client audits and visits.
- Work with the Project Managers, Clinical Trial Assistants, Operations and Lab Staff and Customer service teams within SRL to ensure smooth set up and implementation of studies.
- Make contact with sponsors and/or customer teams to obtain investigator information and patient block numbers.
- Assist with contacting study coordinator and/or Investigator to assess site requirements (mailing address, emergency phone number, supply needs and training material).
- Ensure that all start up orders, supplies and manuals issued to sites are correct and up to standard by completing quality checks of initials orders.
- Creates laboratory manuals and request forms.
- Assist CTAs to resolve holds, communicate result alerts, provides trial support information by contacting sites/sponsor.
- Reviews Data Transfer Agreement for studies involving data management activities.
- Pulls data extracts from LIMS for assigned trials and sends to client data report recipients
- Reviews and distributes invoices for assigned trials.
- Assist in training of other SRL personnel as required
- Support the management team in increasing the profile of SRL across the biopharmaceutical industry.
Education and Experience:
Education:
- Bachelors degree in a biological science (BS/BA)
Experience:
- Previous experience in clinical trial laboratory setting or equivalent.
- Superior Customer service skills.
- Strong Microsoft Office application skills.
- Good problem solving and troubleshooting skills.
Knowledge, Skills, and Abilities:
- Thorough knowledge of the requirements of a clinical lab and clinical trials environment
- Experience in clinical trial management databases and LIMS
- Thorough understanding of the drug development process.
- Demonstrated ability to effectively engage and communicate with clients.
Scheduled Weekly Hours:
40
Work Shift:
Job Category:
Laboratory Operations
Company:
Sonic Reference Laboratory, Inc
Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.