DescriptionWho We Are
Synteract®, a Syneos Health® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.Position Overview
The Project Manager (PM) is responsible for the overall coordination and management of clinical trials from start up through close out activities according to contractual time, quality/ cost parameters. The SPM leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the SPM is accountable for ensuring that all project deliverables meet the client/contract expectations, adhering to company standards/processes while ensuring overall client satisfaction. Specific tasks would include:
- Primary interface with Client representatives as well as staff members in functional departments to ensure the timely initiation and completion of clinical trials.
- Assigned to manage a full range of projects; with preference given to complex, multi-service (e.g., Clinical, Data Management, Biostatistics etc.) to full service, large scale programs.
- Attend and present at client bid defense meetings.
- Prepares proposals, budgets and addendums.
- Represents Project Management on company-wide project teams.
- Interacts with clients and company vendors to ensure that all contractual obligations are met.
- Identifies potential bottlenecks and/or delays; develops and executes contingency plans in order to keep the project on schedule.
- Ensures adequate resource requirements.
- Coordinates initial client meeting identifying project objectives.
- Develops Project Management Plan to include timeline and milestones.
- Coordinates Project Team Meetings, including development of meeting agendas and minutes.
- Coordinates study specific training and other requirements for internal and external staff, as appropriate.
- Conducts daily, on-going communication via telephone and email, responding to inquiries and client requests. Interacts with clients and vendors to ensure that all contractual obligations are met.
- Interacts with company departments relating to project finances and information technology through the use and development of specific tracking and invoicing procedures.
- Manages budget throughout the duration of the project and develops out of scope documentation and costs.
- Manages the project trial master files.
- Produces periodic reports.
- May identify and assist in departmental training requirements including internal and external operations and project manager mentor programs.
- Ensures knowledge of clinical research, clinical therapeutics and regulatory issues, is current through review of journal articles and attendance of relevant professional association meetings.
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
- Bachelor / Master degree, in a related field of study and a minimum of 5 years applicable industry experience or equivalent combination of education and experience.
- At least 3 years of experience as a clinical Project Manager is required (CRO experience preferred).
- A very good understanding of project management techniques.
- Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Very good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook and Internet Explorer
- Effective verbal and writing skills; English + local language, if relevant.
- This job excludes Colorado applicants.
Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.
If you're passionate about bringing clinical trials to life, we encourage you to apply today!