Director, Clinical Operations
Location: Andover Massachusetts
Description: Ora, Inc. is at the momment seeking for Director, Clinical Operations right now, this job will be placed in Massachusetts. Detailed specification about this job opportunity please read the description below. The Director of Clinical Operations will be responsible for the Clinical Operations group, providing guidance and oversight to the project managers and CRAs as well as developing and implementing adequate systems and procedures to ensure efficient day-to-day operations that meet the needs of Ora and its clients.
PRIMARY 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.
Identify/resolve operational, medical monitoring & safety issues to ensure achievement of study milestones, data quality and data integrity.
Develop and implement tracking of operational timelines and milestones.
Provide operational support for the implementation of clinical trials.
Review clinical development strategy to identify operational implications and supervise the implementation of operational plans.
Collaborate with business development 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 guidelines.
Review & 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 the development and implementation of internal policies & procedures that aim to optimize the management of clinical trials.
Supervise & track budget.
Review & approve site contracts, work orders, and invoices.
REQUIRED SKILLS AND ATTRIBUTES:
Minimum 5 years of experience running ophthalmology and or related clinical programs
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 development and management
teams in a fast-paced 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 fast-paced working and business environment.
Thorough knowledge of drug development process and clinical trial management.
EDUCATION:
MS Degree in Science or BSN Nursing
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Ora, Inc..
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This job starts available on: Sat, 11 Aug 2012 10:51:28 GMT