Primary Responsibilities:    Working closely with all members of the AMAG team, the Associate Director /Director of Clinical Operations will develop and execute a strategy to ensure that all clinical study operations activities are conducted efficiently, meet enrollment goals and are in compliance with all applicable regulations and Corporate SOP’s. Primary responsibilities include assisting in trial design and protocol writing; selection and management of external CRO organizations, as well as other vendors; site selection, management and oversight; and supervising personnel involved in completing these operations and processes. Post enrollment activities include an active role in preparing the data for submission to the FDA.

Tasks Performed:    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. Direct the planning and execution of all operational activities involved in area of specific therapeutic indication. Manage and develop the clinical team personnel working on an area of therapeutic indication. Lead project team meetings and supervise personnel involved in all aspects of the clinical research project. Develop and monitor standard operating procedures and processes.

Essential Functions:    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. Develop and assure accurate reporting and measurement of progress of studies for therapeutic indication. Develop study documentation. Overall responsibility for consistency and accuracy of trial information in databases and tracking systems. Responsible for auditing of monitoring and ensuring site recruitment, initiation objectives and patient enrollment targets are met. Communicate effectively with all other departments to accomplish common goals.

Minimum Physical Requirements:   
Desired Education:   
Desired Degree:     The ideal candidate will have a BS/MS/RN or PhD in biological sciences or rela
Desired Major:   
Desired Job Experience:    Progressive 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.
Certifications Required:

Other Qualifications:    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. Thorough understanding of FDA, GCP 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. Additionally, must be able and willing to travel approx. 35% of the time as needed. (International and Domestic)