Clinical Project Manager
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 PM leads cross-functional teams and works with major functional area leads to identify/mitigate/escalate project issues and ensures solutions are implemented. Moreover, the PM is accountable for ensuring that all project deliverables meet the client/contract expectations, adhering to company standards/processes while ensuring overall client satisfaction. This position can be based in Morrisville, NC or Carlsbad, CA offices.
- Primary interface with client representatives as well as staff members l in the functional departments to ensure the timely initiation and completion of clinical trials.
- Assigned to manage a range of projects; from the small limited in scope projects (e.g., data management, etc) to larger full service, more-complex
- Attends and presents at client bid defense meetings.
- 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.
- Develops Project Management Plan to include timeline and milestones.
- Coordinates client project team meetings, including development of meeting agendas and minutes.
- 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.
- Manages budget throughout the duration of the project and develops out of scope documentation and costs.
- Manages the project trial master files.
- Works closely with his/her manager to ensure the timely delivery or completion of project associated tasks.
- Assists with the development of study specific training and other requirements for internal and external staff, as appropriate.
- Ensures knowledge of clinical research, clinical therapeutics and regulatory issues, is current through review of journal articles and attendance of relevant professional association meetings.
Academic & Professional Qualifications:
- Bachelor / Master degree in life sciences, nursing, or a related field of study and a minimum of 3 years applicable industry experience or equivalent combination of education and experience.
- 1-3 years experience as an Associate Project Manager or Project Manager within a pharma, biotech, or CRO experience required -- Candidates without the required industry experience will not be considered.
- 1-2 years experience overseeing / managing project finances, invoices and forecasting.
- Some experience conducting clinical trials a plus.
Skills & Experience:
- Demonstrated understanding of project management techniques.
- Strong verbal, written and presentation skills
- Superior time management, planning, and organizational skills
- Ability to perform multiple tasks effectively in a stressful environment
- Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
- Effective verbal and writing skills; English + local language, if relevant.
What We Have to Offer
Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations
Who We Are
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.
Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.
SynteractHCR’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 SynteractHCR 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.