- Plan, manage and execute one or more clinical studies/programs:
- Lead the SET and coordinate with functional area representatives on all study related activities ensuring timelines, budget and quality are maintained.
- Project management of a clinical study from protocol development up to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving
- Develop, drive and oversee study timelines and budget.
- Ensure regulatory compliance and GCP compliance.
- Provide input on operational aspects of the protocol.
- Provide input on feasibility, country strategy and enrolment plans.
- Develop and implement the clinical operational strategy plan, study management plan and associated documents.
- Responsible for leading vendor selection and management/ oversight, including issue escalation.
- Lead a cross functional team ensuring timely EC/ IRB and regulatory submissions.
- Ensure internal and external study team members are trained on the protocol and study processes, which includes organization of investigator meetings.
- Develop proactive risk mitigation strategy and corrective action plan to address study issues in collaboration with SET
- Responsible for oversight of TMF, always ensuring inspection readiness.
- Report key study performance information, including study start-up metrics, enrolment, data collection timeliness/quality.
- Act as the primary point of contact both internally and externally (e.g., vendors) as applicable for anything study related.
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.
- Support audits/inspections and resolutions of findings.
- Support in the development of new SOPs, guidelines etc. and/ or participate in working groups about new processes.
- Functional leadership and mentorship of junior staff required, Act in advisory capacity to other CPE colleagues within and across TAs.
- A minimum bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
- Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist
- Strong, proven clinical research experience within the pharmaceutical industry.
- A strong command of the drug development process, and specifically, each step within the clinical trial process.
- Experience in overseeing large and/or complex global clinical trials (pharmaceutical or CRO).
- Robust budget forecasting and management experience.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process.
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment.
- Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions.
- Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
- Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges.
- Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
- Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
- Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
- Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge.
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs.
- Excellent written and oral communication skills.
- Maintains computer literacy in appropriate software.
- Postgraduate qualifications, Specialist knowledge e.g., Hematology, Immunology, Nephrology &Transplant, Cardiovascular & Metabolic, Nephrology, Vaccines
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Associate Director, Clinical Portfolio Execution - North Waltham, United States - CSL Seqirus
Description
The Associate Director Clinical Portfolio Execution is accountable for the development of the operational strategy for the clinical study and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical studies/programs. This role typically manages one or more studies/or products, often the most complex in size and scope with minimal oversight and may take on additional responsibilities as defined by the (Sr) Director Clinical Portfolio Execution. This role may also, if assigned, provide oversight and direction to studies run by (Sr) Global Trial Leaders. This role reports to the Senior Director Clinical Portfolio Execution
Responsibilities include: -
Qualifications, Skills and Experience: -
Desired Attributes:-
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL Seqirus employee.
About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus
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