Who We Are
Synteract is a global full-service contract research organization (CRO) with a successful three-decade track record supporting biotechnology, 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. Position Overview The Senior Project Manager (SPM) 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 the full range of clinical projects; from the small limited in scope projects (e.g., data management, etc.
to the full service, large scale, complex programs.
Responsible for a full range of clinical project management responsibilities including managing budget, deliverables, and leading cross-functional teams.
Attend and present at client bid defense meetings.
Prepares proposals, budgets and contracts.
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.
Contributes to the revision of Standard Operating Procedures, guidelines, and departmental policies.
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.
Bachelor / Master degree, in a related field of study and a minimum of 5 years clinical industry experience or equivalent combination of education and experience.
At least 3 years of experience as a Clinical Project Manager and experience at a CRO is required.
Direct experience in conducting large scale full-service clinical trials is a must.
Responsibilities are to have included managing budget, deliverables, and leading cross-functional teams as a clinical Project Manager.
Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
Good proficiency in Microsoft Word, Excel, and PowerPoint, Outlook and Internet Explorer
Effective verbal and writing skills; English + local language, if relevant.