Director of Clinical Operations—North Carolina

Director of Clinical Operations North Carolina

Tanner and Associates is recruiting a Director of Clinical Operations. This job is based out of North Carolina.

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The Director of Clinical Operations will plan, execute, and supervise all operational activities pertaining to clinical studies, oversee the performance of clinical operations staff, and lead departmental activities.

Key Accountabilities / Responsibilities :

• Ensures that proper activities are undertaken for timely and quality set-up, planning, and management of clinical trials to meet corporate objectives.
• Manages interdepartmental activities specific to implementation and conduct of protocols may lead study teams.
• Reviews and approves clinical outsourcing specifications for RFPs and may manage CROs for their performance.
• Ensures the collection of high-quality clinical data; participates in the analysis of clinical data.
• Ensures departmental processes are efficient and comply with applicable regulatory and company requirements.
• Ensures proper and timely resolution of CQA audit findings.
• Leads and / or coordinates initiatives to improve processes within Clinical Operations.
• Ensures a high level of customer service for clinical study sites and internal clinical study teams.
• Develops and maintains long-term relationships with key investigators, opinion leaders, and other industry leaders.
• Stays abreast of the latest developments in clinical trial management, drug development, and, where possible, contributes to advances in the field.
• Promotes and communicates the role of the Clinical Operations department (internal / external).
• Provides input and due diligence to in-licensing proposals.

Requirements :

• MS, MSN, MBA, PharmD, MPH in biological sciences or related field, or BS degree will be considered with substantial clinical trial and personnel management experience.
• 14+ years of progressive experience in life sciences, with 10+ years of biopharmaceutical industry experience.
• 5+ years of management experience.
• Experience in Immunology and / or Cardiovascular therapeutic area preferred.
• Expert knowledge of regulatory and clinical practices (GCP, etc.).
• Demonstrated matrix leadership skills, including leading interdisciplinary trial execution teams.
• Detailed knowledge of the concepts of clinical research and drug development.
• Proven ability to provide scientific and clinical expertise to a clinical development program.
• Proficiency in clinical studies involving complex design issues.
• Experience with regulatory filing.
• Experience with management of multinational clinical trials.
• Ability to travel 25%-50% both domestic and internationally.
• Strong time management and organizational skills, proven ability to prioritize workload, manage to deadlines, and be accountable.
• Attention to detail and accuracy in work.
• Demonstrated aptitude and knowledge in relevant therapeutic area and / or ability to learn and integrate new / different therapeutic areas.
• Strong verbal, presentation, and technical writing skills.
• Solid working knowledge of word processing, spreadsheet, email, and presentation software (MS Office suite).
• Hands-on, team player mentality.
• Experience and comfort in working both independently and as part of a multifunctional team.
• Commitment and ability to handle high workloads, demanding situations, and deadlines.

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