- Oxford Immunotec Global PLC
70 Bolton St
This position is a member of the global Clinical Affairs team and will be responsible for the planning, implementation, execution and management of one or more Oxford Immunotec's global clinical studies and registries. The Sr. Clinical Project Manager will execute high quality, integrated cross-functional plans for the project/clinical trial while ensuring adherence to the budget, scope and schedule requirements throughout the process. Partners closely with internal partners including Medical Affairs, R&D, Legal, Finance and Marketing and external vendors such as Investigators managing Investigator Led Studies and CROs. This role will manage up to two direct reports.
* Report study progress and identify and communicate issues and risks with a resolution plan, including identifying unrealistic timelines? Ensure all trial deliverables are met according to timelines, budget, and resource requirements? Lead investigator meetings and protocol training meetings. Accountable for all internal clinical meetings related to assigned clinical trial(s)? Lead the clinical protocol development process in collaboration with Clinical leadership: responsible for clinical protocol development, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents; obtain approval from internal review boards. Collaborate with the Clinical leadership and investigators to ensure their feedback is adequately integrated into protocol? Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational management activities of CROs, management of global resources, expertise, and knowledge within the CRO/vendor? Lead efforts in study start-up, including study feasibility and site selection? Collaborate with Legal to create and approve CDAs and CTAs and assure fully executed forms are returned and distributed to appropriate internal parties and maintained in TMF/SMF? Forecast trial resources needs, including external costs: accountable for the development, management and tracking of trial budget working closely with CRO Management and internal Accounting. Accountable for accuracy of trial information in all trial databases and tracking systems? Create and maintain clinical project files to internal standards and regulatory requirements and ensure documentation from Investigators meets FDA/GCP/ICH guidelines? Collaborate effectively with other departments and functional groups to meet study timelines and corporate goals? Provide on-boarding and mentoring of new team members as well as guidance, leadership and career development to direct report(s)
* Bachelor's degree or equivalent experience is required? 7 years global experience as a Clinical Project Manager or relevant work experience? Experience in diagnostic industry preferred, experience in medical device or pharmaceutical industry will be considered
Competencies? Excellent oral and written communication skills? Strong interpersonal skills with demonstrated successful team leadership and participation? Strong command of study compliance and local regulations? Advanced computer proficiency, especially MS Office? Proven skill in managing and prioritizing multiple tasks simultaneously, with critical attention to detail? Ability to travel 20 - 40% (domestic and international)
Physical DemandsThe physical demands described within the Overall Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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