Senior Project Manager - Anywhere, US
Office-based or Remote-based
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
The Project Director (PD) 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 PD leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the PD 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.
- May participate with company senior management in marketing and business development activities including professional meetings, trade shows, seminars and client capabilities meetings.
- Contributes and participates in the analysis of departmental resource requirements.
- Identifies and assists in departmental training requirements including internal and external operations and project manager mentor programs.
- Contributes to the development and revision of Standard Operating Procedures (SOPs) and departmental policies.
- May participate in the analysis and development of Project Management Department budgets.
- Bachelor / Master degree, in a related field of study and a minimum of 8 years applicable industry experience or equivalent combination of education and experience.
- At least 5 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.
If you're passionate about bringing clinical trials to life, we encourage you to apply today!
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.