Senior Project Manager / Clinical Operations

Senior Project Manager / Clinical Operations:
This position lies between the Project Manager and the Project Director an includes the following tasks/duties:

•Acts as the primary point-of-contact liaison with the Sponsor to provide outstanding customer service, including participation in proposal activities and Sponsor presentations.
•Oversees and manages all aspects of a clinical research trial with minimal support from line Manager.
•Manages the clinical study budget, ensuring study remains within scope and that any out of scope activities are identified and handled as appropriate.
•Establishes tracking metrics to monitor study progress and ensures that the Study Team progresses towards the study goals.
•Prepares and presents study status updates for Sponsors and senior management.
•Leads the Study team with the goal to contribute towards efficient management of trials.
•Prepares and/or reviews protocols and other study documentation as required by the Sponsor and in collaboration with the Medical Writing department.
•Designs and develops the Case Report Form (in collaboration with the Biometrics department).
•Designs and develops clinical trial documents such as Project Plans, monitoring guidelines, etc.
•Oversees all aspects of study site management to ensure a high quality of data is generated by Investigative sites, resulting in consistently low query levels and in acceptable Quality Assurance reports.
•Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports.
•Manages investigative site recruitment activities including feasibility work (designing of investigator questionnaire, identification of potential sites, performing initial site contacts in collaboration with the CRA’s. writing of feasibility report), organizing for pre-study visits to be performed approval of participating sites post pre-study visits (with the Sponsor if required), ensuring sites are informed of their participation or not.
•Manages and coordinates the recruitment of investigators, overseeing collection of site essential (regulatory) documents in collaboration with the CRA’s, negotiation of Investigator fee budget range and template payment schedule with Sponsor, and aiding CRA’s in negotiation.
•Ensures timely submissions to regulatory authorities and IEC/IRB submissions (in collaboration with the Regulatory Affairs department), arranges translation of study related documentation, organization of meeting or delegates these tasks as appropriate.
•Negotiates investigative site study budgets and assists with the execution of investigator contracts with support from the legal department.
•Conducts all types of site visits when required, including pre-study, inflation, monitoring, and close out visits, in accordance with the protocol, local laws, ICH-GCP and Company’s SOP’s.
•Prepares accurate and timely visit reports from all site visits.
•Reviews and approves site visit reports from all site visits conducted by study team.
•Alerts Biometrics to emerging issues with CRF completion.
•Communicates effectively with both site personnel and Company’s management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues.
•Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Company’s high quality and ethical image.
•Maintains study tracking, in accordance with the demands of the study.
•Performs data management activities, including ongoing in-house CRF and data listing review in a timely fashion, query resolution, and assists data management personnel resolve data discrepancies.
•Oversees management of Serious Adverse Events with the CRA’s and Pharmacovigilance according to the procedures defines by the study team.
•Demonstrates a full understanding of the SAE reporting process and when required, may write narratives and follow-up on SAE’s.
•Liaises with data management to resolve data discrepancies and ensure all data management study goals are met.
•Mentors, trains, and supervises staff as a functional level.
•Reviews clinical study reports.
•Conducts feasibility work when requested.
•Assists the business development effort by providing input to the development of proposals and attendance of bid meeting as required.
•Interacts with internal work groups to evaluate needs, resources and timelines.
•Initiates/approves payment requests for investigators.
•Develops/reviews SOPs when required.
•Travels as necessary according to project needs.
REQUIREMENTS
Requirements:
•Bachlors degree and at least 6/7 years experience of clinical research with at least 2 years of experience in project management, managing all aspects of clinical trials.
Preferred Experience:
•Experience in managing international studies is a plus.
•Line management experience is a plus.
•Oncology experience is a plus.
•CRO experience is definitely preferred. Pharma candidates will be considered.
Benefits:
•20 days vacation and 5 days of personal/sick time per annum.
•Life insurance and health benefits.
•401K plan (entry after 6 months).
•Up to 2 discretionary bonuses are possible per year – summer and end of year.

***TO BE CONSIDERED FOR THIS OPPORTUNITY, PLEASE FORWARD AN MS WORD (.doc) VERSION OF YOUR RESUME ALONG WITH REFERENCES, AND SALARY REQUIREMENTS TO [Click here for email]***