Clinical Development Department –Clinical Manager Supervisor: Director of Clinical Development Department: Clinical Development | Responsibilities include, but are not limited to: · Ensure that management’s clinical development objectives are met · Provides assistance in the strategic and operational direction, planning, execution and interpretation of clinical programs and data collection - Implement and manage assigned clinical programs and clinical studies. This includes writing of study protocols, informed consents, case report forms, study reports and summaries, monitoring plans, investigators brochures and other study-related documents that may include IND, NDA, BLA etc,.
- Independently evaluate and recommend selection of investigators/study sites; actively participates in the identification of potential sites
- Independently train investigators, coordinators and other trial staff in data collection methods to ensure collection of study subjects data is accurate, complete and conforms to project data standards and protocol requirements
- Manage study and/or program budgets and timelines including clinical site budget and contract negotiations
- Assist management in resource planning
- Responsible for directing, managing, training and performance evaluation of direct reports.
- Responsible for ensuring SOP and regulatory compliance of staff and clinical sites in assigned clinical programs
- Responsible for CRO selection, development of RFPs, budget negotiations and managing CROs in assigned clinical programs
- Provides assistance to the CRO in the development of Statistical Analysis Plan, Data Management Plan and Quality Control Plans
- Responsible for projecting and managing investigational drug supply use for assigned clinical sites
- Monitor and close-out clinical studies, ensuring adherence to protocol, accurate data collection on CRFs via comprehensive source document verification
- Develop solutions for logistical and operational issues that arise during trial execution and communicate these in a timely fashion to investigators, coordinators and staff
- Ensures that written reports for product complaints and serious unexpected events are properly identified and reported appropriately.
- Responsible for the development of SOPs, systems and policies supporting clinical studies
- Maintain a high level of professional expertise through familiarity with clinical literature and participates in project team meetings.
- Attends scientific meetings, as necessary and required.
Background Qualifications: · Bachelor’s degree in a relevant scientific discipline is required · Experience managing CRO’s · At least 8 years of relevant clinical experience in the biotech/pharmaceutical industry or equivalent with a solid track record of managing effective teams · Knowledge of FDA regulations, GCP and ICH guidelines required · Excellent communication and interpersonal skills · Able to lead teams and motivate team members · Able to prioritize and handle multiple tasks · Proficiency with MS Word, Excel, Outlook, and PowerPoint · Must be willing to travel as required Other Knowledge and Skills Required: § Experience in and strong understanding of clinical trial design. § Strong team player. Ability to work independently and in a multidisciplinary project team environment, including interactions with external vendors and CROs. § Attention to detail, accuracy, and strong organizational and problem-solving skills. § Leadership skills as well as demonstrated clear and concise verbal and written communication skills. Ability to influence others effectively. § Ability to skillfully manage competing priorities and projects and handle multiple tasks simultaneously. § Dedication to quality and reliability in all work tasks. § Self-motivation, eagerness to grow professionally and commitment to self-development. To apply please send resumes to sreed@criticalresource.net
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