9 days old

Clinical Research Project Manager

Kelly Services
Arden Hills, MN 55126
Kelly Scientific Resources has an fantastic opening for a Clinical Research Project Manager in Arden Hills, MN for a growing international specialist healthcare company.


+ Ensure that all clinical studies comply with the clinical protocol, relevant Standard Operating Procedures (SOPs), the most recent ICH requirements for Good Clinical Practice (GCP) and other applicable regulations

+ Evaluate and select contractors (CROs, SMOs, central laboratories, contract monitors etc.) in accordance with the Company's SOPs

+ Define the scope of work to be contracted out and agree to the roles and responsibilities of each party involved in the study

+ Supervise outsourced tasks and services and manage contractor relationships

+ Provide guidance to the clinical project team to ensure that the objectives of the clinical study are met

+ Assist in the preparation of the clinical study budget and manage clinical study to approved budget

+ Ensure that adverse events (AEs) from clinical studies undertaken are reported in accordance with the Company's procedures and to satisfy ethical and regulatory requirements

+ Participate in the identification and selection of clinical study sites

+ Ensure that regulatory documents are obtained from study sites and that study and site files are set up and maintained in accordance with GCP and relevant SOPs

+ Ensure clinical sites are ready for inspection where appropriate

+ Co-monitor clinical study sites with the external monitor where necessary

+ Oversee and assist in the preparation, review and approval of clinical study documents (e.g. agreements, protocols, informed consent forms (ICFs), case report forms (CRFs), lnvestigational Brochure, and study reports)

+ Participate in project meetings and provide status reports and timelines for the critical aspects of the project plan

+ Coordinate the distribution of clinical study supplies to contractor or sites

+ Participate in planning and presenting at investigator meetings

+ Ensure that regulatory and ethical approval is obtained for all clinical studies prior to site initiation

+ Ensure that clinical trial insurance is obtained for all clinical studies prior to site initiation

+ Ensure that new clinical studies are added to the appropriate study registries

+ Assist with the interim and final reporting and data analysis of clinical results

+ Provide input into the planning, timelines and costing of new clinical studies

+ Assist with preparation and/or review of SOPs for clinical research

+ Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with company values

+ May require line management and team mentoring responsibilities

+ Complete additional tasks considered necessary to meet business and customer requirements as indicated by the Line Manager

**Education and Experience**

+ BA/BSc degree in life sciences or health related discipline (post-graduate degree preferred)

+ Extensive relevant experience in clinical development organization, managing global clinical studies, preferably including Phases I-IV, preferably oncology

+ Understanding of the device development process, ideally to include participating in regulatory submissions.

+ Working knowledge of GCP/ICH guidelines and FDA/EMEA regulations

+ Experience working in a matrix environment, ideally across countries

+ Experience with forecasting and budgeting

**Skills and Attributes**

+ Ability to effectively manage/prioritise multiple priorities

+ Problem solving ability with the tenacity to drive projects to conclusion

+ Excellent organisational skills, attention to detail, commitment to quality and the ability to work independently

+ Proficiency in Microsoft Office software (PowerPoint, Word, Excel, Project)

+ Excellent oral and written communication skills

+ Excellent interpersonal skills

+ Ability to travel domestically and internationally

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2018-12-05 Expires: 2019-01-05

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Clinical Research Project Manager

Kelly Services
Arden Hills, MN 55126

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