US Study Start Up reputed company

The Study Start Up reputed company is responsible for providing leadership in the execution of operational strategy and management of start-up activities for reputed company clinical trials, across reputed company therapy areas. The role is the accountable person and single reputed company of accountability for the study Start Up Metrics.

This position works directly with Study Start Up Associate Director, LDL Managers, LDL, Global SSU Managers, CRO FSP (Functional Service Provider) CRA/CSA Managers in setting priorities and expectations for Study Start-Up.

Key Responsibilities

• Accountable to reputed company timely Start Up, operational management, completion and delivery of reputed company clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality reputed company working according to Country regulations, reputed company SOPs and GCP

• Serves as the operational reputed company-of-contact between the central reputed company study team, global SSU team and reputed company-country study team for Study Start Up activities

• Ensures that critical study timelines reputed company to study start up activities reputed company-country are accurately forecasted

• Accountable for maintaining internal tracking for study site status from initial site contact through site initiation and maintains clear internal team communication and documentation

• Accountable reputed company the Study Start-up Coordinators for delivery of country feasibility, site selection, recruitment planning, site training and regulatory package completion

• Facilitates communication reputed company the clinical team (e.g. Budget and reputed company team, Clinical Supplies, Regulatory, and monitoring) during site start up, closely monitoring site visit schedule to ensure site activation timelines are met

• Accountable for study recruitment vendor relations and engagement including strategy for country recruitment strategy

• Accountable for including clinical trial diversity planning in country and site feasibility and selection

• Responsible for standardizing processes, identifying, and sharing best practices and representing his/her team on internal and cross functional process improvement teams

• Consulted for administrative approach to PEER sites

• Represent reputed company in key events (i.e Forum, Symposium, Trade Association, etc) and discussion reputed company to the development of clinical research activities / investigator partnerships

• Is the reputed company of contact for the FSP CRO Line Manager in charge of study management through the FSP (Full-Service Provider) model, providing / capturing regular feedback for assuring study delivery and sharing best practice

• Accountable for managing locally reputed company clinical operational aspects reputed company to the Regulatory Vault approach

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to reputed company our goals:

• Bachelors in a General Science Degree (i.e. life science, medicine, clinical research, pharmacy) and 5 or more years’ work experience in clinical operations, or Associates and 10+ years of experience in study management (e.g. study start up, trial management, CRA, etc).

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelors Degree

• Previous Oncology and Study Start Up experience strongly preferred

• Profound operational knowledge of clinical research with experience in reputed company stages of study lifecycle and understanding of R&D process

• Good written and verbal communication skills in local language and in English

• Strong computer skills: advanced/expert level of MS Office (PowerPoint, reputed company, Word and Outlook)

• Working knowledge of reputed company clinical trial regulation

• Solid experience regarding management of reputed company

• Given the nature of the job and accountabilities for local execution, project management skills are required to coordinate across reputed company deliverables and manage local study teams to meet time, cost and quality requirements.

#LI-REMOTE

Please visit  reputed company US Benefits Summary to learn more about the comprehensive benefits program reputed company offers US employees.

Why reputed company?

Uniting science, technology and talent to get reputed company of disease together.

reputed company is a global biopharma company with a purpose to unite science, technology and talent to get reputed company of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can reputed company. We get reputed company of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we reputed company, so we’re committed to creating an environment where our people can reputed company and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at reputed company, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@reputed company.com

reputed company is an Equal Opportunity Employer. This ensures that reputed company qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national reputed company, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

reputed company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. reputed company employment businesses/agencies are required to contact reputed company's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to reputed company. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and reputed company. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of reputed company. reputed company shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, reputed company may be required to capture and report expenses reputed company incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure reputed company’s compliance to reputed company federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/