Associate Director, Clinical Operations

Apply by eMail:15341789.185@jobfrenzy1.com

Description:
Job Summary:
Oversee a team of clinical study managers as they support implementation of clinical trials and monitor clinical study sites. Assist in preparing documents. Review development plans to identify operational implications and oversee completion of clinical trial protocols. Provide supervisory guidance to Clinical Study Managers. Perform clinical study management activities for assigned projects. Support Operational Committees.

Responsibilities:
Manage internal resources, external partners, consultants, vendors and external budget to ensure the timely and cost-effective implementation of the Clinical Development Plan for specified programs. Provide operational support for the implementation of clinical trials. Approve CRO oversight plans. Review clinical development strategy to identify operational implications and supervise the implementation of operational plans. Interface with strategic alliance and co-development partners to ensure smooth and expedited execution of global and regional projects, including the formulation of the scope of the work and transfer of obligations.
Supervise, manage, direct and mentor a team of clinical study managers. Accountable for the training and development of staff, monitoring consistent process application and encouraging the sharing of best practices. Ensure compliance with GCP and SOP.
Identify/resolve operational, medical monitoring and safety issues to ensure achievement of study milestones, data quality and data integrity. Review and approve monitoring plan. Assess and recommend CROs and preferred vendors for implementation of clinical development plan for multiple global programs. Review and approve contracts, work orders and invoices within grant of authority. Participate in Operating Committees as appropriate. Interface with appropriate departments to facilitate negotiation/issue resolution for study related agreements, contracts, informed consent forms, etc. Represents Daiichi Sankyo in operations or implementation committees overseeing co-development of therapeutic area programs with partners.
Participate in the development and implementation of internal policies and procedures that aim to optimize the management of clinical trials. Supervise and track budget. Review and approve site contracts, work orders, invoices prior to study lead/TA Head approval.

Education/Experience
MS Degree in Science; minimum 7 years of experience in pharmaceutical research, with at least 5 of those years in clinical development. Experience with CROs/alliance partners preferable. Knowledge of pharmaceutical business, worldwide drug development and regulatory process. Expertise in clinical trial design, conduct and interpretation of scientific data. Independent thinking, creativity and innovation. Ability to lead and manage complex global and multinational drug development programs/teams and to deliver high quality products. Strong interpersonal skills and ability to interface effectively with multinational development and management teams in a multicultural working environment. Excellent communication, presentation and negotiation skills with emphasis on building consensus. Ability to effectively manage interactions with development partners and academic thought leaders ensuring optimal cooperation for achieving program and department goals. Ability to listen, motivate, lead and facilitate issue resolution in a multicultural working and business environment. Thorough knowledge of drug development process, clinical trial management, reporting process; GCP / SOP; EDC use; Budgeting process; CSR writing and other docs; ability to oversee studies outside preferred TA.

Requirements:
See Above

Education: Not Specified

Experience: Not Specified

Travel: None

Apply by eMail:15341789.185@jobfrenzy1.com

Job Created: Fri Oct 23 2009 04:27:05 AM
Last Modified: Fri Oct 23 2009 04:27:05 AM