This person will be a key contributor to the company’s clinical development and
primarily responsible for the hands-on management of early and late-stage clinical studies in ultra-rare disease indications. This position reports to the Senior Director of
Global Clinical Research Operations. This person will work closely with the Chief Medical Officer and Commercial Operations Management in assisting with protocol feasibility analysis, country assessment(s), site identification, patient recruitment and ultimately, lead the planning to ensure successful execution and completion of the clinical trial(s).
? Drive activities internally and externally to ensure successful execution and reduced cycle times for clinical trial activities.
? Assist in protocol feasibility analysis, country assessment, site identification, and patient recruitment planning.
? Identification and management of Clinical Research Organization(s) and other vendors as needed.
? Identify investigators and provide assistance to facilitate timely selection of investigators and sites
? Develop recruitment plans
? Manage all logistical and operational activities for the clinical trials
? Implement monitoring plans
? Design CRF completion guidelines
? Assist in the preparation of the draft protocol, draft CRFs, and template informed consent
? Create study documents such as Operations Manuals, Laboratory Manuals, and Pharmacy Manuals
? Collect and review essential documents for study start-up
? Maintain internal trial master file to ensure inspection readiness
? Ensure that the site personnel have a good understanding of the protocol, the investigational product and the requirements of the study and that they can fulfill their obligations to conduct the study accurately and to deadlines.
? Interact with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete and can be used as a source of reference.
? Maintain project tracking system on an ongoing basis to ensure that progress regarding the sites can be tracked.
? Prepare and manage detailed project plan in MS Project.
? Provide regular status updates of project progress to Head of Program Management and Chief Medical Officer.
? Assist with the preparation and presentation at investigator meetings
as required to ensure that the clinical and investigational site staff
team is well informed about the study and related procedures.
? Establish and ensure consistent use of clinical project planning
? Educated to degree level (biological science, pharmacy or other health
related discipline preferred) or equivalent nursing
? Minimum 5-7 years of industry experience within clinical
research/operations and 3 – 5 years monitoring experience.
? Experience managing global clinical trials in rare diseases with orphan
drug designation is a plus.
? Excellent interpersonal, verbal and written communication skills
(including presentation skills).
? Able to take initiative and work independently with sense of urgency
in completing assigned tasks.
? Flexibility towards work assignments, new learning and travel
(overnight, weekend and international travel may be required).
Flexibility to accommodate travel up to 30%.
? Ability to manage multiple and varied tasks and prioritize workload
with attention to detail.
? Team player with outstanding negotiation skills and organizational
? Computer Proficiency: MS Office suite and working knowledge of MS
? Preparation and maintenance of a clinical study budget.
NOTES Synageva BioPharma is a publicly traded biopharmaceutical company with
headquarters, research and development facilities in Lexington, MA, and
research and production facilities in Athens, GA. Synageva was formed to
concentrate on novel orphan treatments for rare diseases. Our lead
program, SBC-102, an enzyme replacement therapy for LAL Deficiency, is
in clinical development and has been granted orphan designation by the
FDA. LAL Deficiency is a rare, serious and devastating disease that leads to
significant morbidity and mortality. Synageva has additional orphan
products in development. To ensure that these therapeutic candidates
reach patients in need, Synageva has recruited a team with a proven
record of discovery, development and commercial experience within rare
Our work is based on creating value for patients and their healthcare
providers, our shareholders and our employees. Our success brings new
treatments to patients and providers. We are building a sustainable
business and value for our shareholders because good medicine is good
business. Our culture attracts and retains principle-minded individuals of
integrity, drive, energy and passion.
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