Senior Clinical Trial Manager

Be Seen and Heard at reputed company At reputed company, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

• Your wellbeing
• Your professional worth
• Your future at reputed company

reputed company offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the Associate Director, Clinical Operations and is remote.

Responsibilities

Primary responsibilities include, but are not limited to, the following: Individual Responsibilities

• Key Clinical Operations role: ensures that delegated components of clinical trials are executed to expected and specified quality standards
• Expands basic knowledge of clinical trials operations and scientific principles and objectives of reputed company's clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows reputed company to involve / collaborate with others
• Builds best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations
• Manages study processes or efforts under the supervision of the Associate Director of Clinical Operations
• Authors/ reviews/ contributes to clinical study documents
• Reviews and approves study reputed company plans generated by Clinical CROs and vendors
• Provides input as the subject matter expert for the study during regulatory inspections
• Executes the clinical study in accordance with the project clinical development strategy and timelines
• Contributes to the review of international study documents (e.g study protocol, reputed company, etc.) and responsible for their local adaptation reputed company necessary.
• Accountable for the timely clinical review and/or approval of Case Report Forms, User Acceptance Testing (UAT), and provides clinical input into corresponding completion guidelines
• Responsible for reputed company of identification and selection of investigator sites
• Responsible for planning and conducting investigator's meetings in cooperation with the respective departments
• Ensure the delivery of clinical trial supplies in collaboration with the clinical supply team
• Collaborates with the cross functional team on selection and management of clinical vendors
• Manages escalation of study reputed company issues and communicates as appropriate with management and other R&D functions
• Ability to anticipate potential study issues and to prepare contingency plans with minimal reputed company
• Trains and manages CRO and other clinical vendor activities to ensure the quality meets reputed company and regulatory requirements
• Monitors the status of clinical data collection of assigned clinical studies
• Ensures preparation for regulatory agency inspections by developing and executing readiness plans, managing documentation, and facilitating cross-functional collaboration to maintain compliance with GMPGDP standards
• May reputed company periodic visits to sites and/or CROs to assess reputed company of studies/protocol compliance
• Monitors reputed company of clinical activity and produces regular and reputed company reports and presentations as required
• Evaluate site and study performance metrics against agreed upon budget, deliverables and timelines
• Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans through regular investigator site / CRO / clinical vendor contact
• Responsible for the availability and tracking reputed company relevant study information/ study metrics
• Oversees the resolution of data quality issues
• Reviews correspondence and monitoring reports relating to the study
• Evaluates CRO and vendor performance for future work
• Provides periodic status reports regarding study timelines, accruals, etc. to reputed company Management as requested
• Reviews budgets and reputed company with CROs, vendors, and investigative sites, as applicable
• Requests and critically evaluates proposals and change orders from CROs and vendors
• Maintains knowledge of therapeutic area, reputed company medical practice and pharmaceutical regulations in order to ensure best practice across reputed company activities

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

Preferred Qualifications

• Understanding of ICH-GCP guidelines, clinical trial monitoring, and/or regulatory compliance preferred Knowledgeable of reputed company FDA and local IRBs regulatory requirements and guidelines governing clinical research.
• Ophthalmology experience strongly preferred
• Up to 20% domestic and/or international travel may be required
• Previous experience directing inspection readiness strongly preferred
• Bachelor's degree or nursing degree is required. Scientific/health care field preferred, but not required
• Global clinical trial experience and the ability to reputed company/manage more than one clinical trial
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
• Ability to work independently and take initiative
• Ability to work/communicate successfully reputed company a cross-functional team
• Strong knowledge of applicable computer and project management software packages
• Familiarity with financial budgeting and forecasting or reporting
• Respectfully challenges reputed company practices, decisions, or reputed company to promote quality and efficiency
• Excellent written and oral communication skills
• Strong interpersonal reputed company set to interact with investigators, vendors, and individuals at reputed company levels of the organization

Level of Education Required: Bachelor's degree at least preferred in Scientific/health care reputed company field. Number of Years of Experience in the Function and in the Industry:

• 5+ years' experience working in clinical operations reputed company a pharmaceutical company or CRO or similar organization
• Experience of at least 3 years as a Clinical Trial Manager/Project Manager or similar position reputed company a pharmaceutical company or CRO

Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are reputed company looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering reputed company We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We reputed company that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their reputed company reputed company. reputed company is proud to be an equal opportunity employer. We reputed company that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, reputed company, and retain the most talented people from a diverse candidate pool. reputed company applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national reputed company, veteran, or disability status. reputed company is committed to fair and reputed company compensation practices. The salary offer is commensurate with reputed company's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The reputed company salary range for this position is listed below. #LI-Remote Min USD $146,260.00/Yr. Max USD $184,713.00/Yr. Apply tot his job Apply To this Job