Description
Single Sponsor Sr Project Manager (Interim Analysis) - urgent needed
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Project Leadership and Delivery:
- Manages a project as Project Manager overseeing interdisciplinary clinical research programs ensuring compliance with Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
- Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement.
- Leads clinical team to ensure quality, timelines and budget management.
- Accountable for the financial performance of assigned projects
- Accountable for all project deliverables for assigned projects and/or project regions.
- Coordinates activities and deliverables of all project conduct partners and proactively identifies and manages issues. Reporting and Communication:
- Accountable for maintenance of project information on a variety of databases and systems.
- Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
- Responsible for project management components of inspection readiness for all aspects of the project conduct, including Trial Master Files.
- Provides oversight for development and implementation of project plans in accordance with Controlled Documents.
- Independently prepares, coordinates, and presents project material at internal and external meetings.
- Directs the activities of assigned Project Support staff; line manages and mentors other project management team members and clinical staff; facilitates team building and communication.
- Prepares project management reports for clients and management.
- Implements resource strategies to achieve project goals.
- Develops contingency planning and risk mitigation strategies to ensure successful delivery of project goals. Business Development
- Participates in bid defense meetings where presented as potential project manager/director.
- Develops strong relationships with current clients to generate new and/or add-on business for the future.
- Keeps a current awareness of business unit’s and assigned projects’ therapeutic environment and drug development trends Management:
- May train and support new Project Managers. Facilitates team training in accordancewith protocol and/or project requirements, including therapeutic, protocol specific, and process training.
- May be required to line manage other project management team members and clinical monitoring staff
Qualifications
- Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience.
- Previous experience as a CTM/PM in a CRO or Pharmaceutical company. Strong knowledge of Good Clinical Practice/ICH guidelines, regulatory requirements, drug development process and clinical monitoring procedures.
- Clinical research organization (CRO) and relevant therapeutic experience preferred.
- Strong ability to manage time and work independently.
- Experience managing multiple countries on a global level.
- Excellent communication, presentation, interpersonal skills, both written and spoken
- Flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment.
- Ability to travel as necessary (approximately 25%).
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
