THIS IS A 100% ONSITE ROLE
Summary: Working closely with all members of the organization, the Associate Director will create and execute a strategy to ensure that all clinical study operations activities, in addition to meeting enrollment goals and are in compliance with all applicable regulations and Corporate SOP's. Responsibilities include assisting in trial design and protocol writing; selection and management of external CRO organizations, as well as other vendors; site selection,
Essential Duties and Responsibilities:
1. Operational oversight of clinical development programs within therapeutic areas. Plan and initiate clinical trials including protocol development; evaluation of investigators; evaluation, selection and training of CROs including monitors; review and negotiation of study budgets; CRF design coordination; overseeing management of Clinical Trial Material shipments for therapeutic area and ensuring proper collection and reporting of adverse events through participation in safety review team meetings. Tasked with directing the planning and execution of all operational activities involved in area of specific therapeutic indication.
2. Assess the adequacy of standard operating procedures and processes and if needed develop additional ones.
3. Forecast trial resources needs (headcount and external costs) for therapeutic area. Accountable for the development, management and tracking of budgets and management of payments and timelines to ensure trial execution is within budget and within established timelines. Create and assure accurate reporting and measurement of progress of studies for therapeutic indication.
4. Develop study documentation. Responsible for consistency and accuracy of trial information in databases and tracking systems.
5. Accountable for auditing of monitoring and ensuring site recruitment, initiation objectives and patient enrollment targets are met.
6. Communicate effectively with all other departments to accomplish common goals.
? Experience in the therapeutic areas of oncology and/or imaging studies preferred.
? Ability to interact positively with all levels of staff and liaise successfully with all levels of management in addition to being a strong team player.
? Strong understanding of GCP, FDA and ICH guidelines.
? Strong organizational/project management/interpersonal skills.
? Strong writing and computer skills, performance oriented.
? Adept at developing and implementing metrics and clinical study patient recruitment strategies and exhibit strong presentation skills.
Education: PHD/MS/BS/AS and preferred type of degree:
? The ideal candidate will have a BS/MS/RN or PhD in biological sciences or related field.
Experience Level (Years):
? Experience in Clinical Operations/Research/Development with strong background in pharmaceutical, CRO and/or biotech industry.
? Minimum of 7-10 years of related experience is desired
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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