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Clinical Trial Manager - REMOTE, USA
Deerfield, IL
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a remote Clinical Trial Manager. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
The Clinical Trial Manager (CTM) will be a member of the client's Clinical Operations team.
RESPONSIBILITIES
* Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.
* Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials
* Provide direction and leadership in CRO and vendor selection and management.
* Knowledge of regulatory start up process and planning in support of study start up
* Managing and maintaining high performing clinical teams
* Coordination of global clinical trials
* Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
* Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
* Be responsible for and manage clinical research activity of Clinical Operations team
* Estimate, track and critically analyze vendor financial spend on study
* Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
* Provide guidance, direction, and management to site monitoring activity
* Coordinate patient enrollment activities and mitigation planning
* Coordinate study supplies with regulatory and clinical supplies functions
* Negotiate contracts with vendors of clinical trial services
* Review Informed Consent Forms, CRFs, and study related materials
* Plan and participate in investigator meetings
* Assist and support data query process
* Assure regulatory compliance of investigational sites with the client's SOPs and FDA and ICH guidelines
* Ensures trial master file is current and maintained.
EXPERIENCE
* At least 3 years of experience in clinical trial management
* Experience in CNS and / or oncology is preferred
EDUCATION
* BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
QUALIFICATIONS
* Proven Management of people in a matrixed environment
* Management of global clinical trials
* Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
* Demonstrated ability to work independently and in a team environment
* Travel required. Must be willing to travel 15-25%, including international travel
* Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
* Excellent oral and written communication skills and strong organizational abilities
* Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
Description of Work Environment
* Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
To be a best-fit your strengths must include:
* Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
* Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
* Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
* Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
* Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
* Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
We are currently searching for a skilled professional to join a well-known client's team as a remote Clinical Trial Manager. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
The Clinical Trial Manager (CTM) will be a member of the client's Clinical Operations team.
RESPONSIBILITIES
* Manage complex Phase 1, 2, 3, and 4 clinical trials as part of a global clinical operations team.
* Demonstrate oversight of CROs and work in a quality framework that supports confirmatory trials
* Provide direction and leadership in CRO and vendor selection and management.
* Knowledge of regulatory start up process and planning in support of study start up
* Managing and maintaining high performing clinical teams
* Coordination of global clinical trials
* Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
* Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Product Development, Project Management and Regulatory to ensure operational excellence.
* Be responsible for and manage clinical research activity of Clinical Operations team
* Estimate, track and critically analyze vendor financial spend on study
* Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
* Provide guidance, direction, and management to site monitoring activity
* Coordinate patient enrollment activities and mitigation planning
* Coordinate study supplies with regulatory and clinical supplies functions
* Negotiate contracts with vendors of clinical trial services
* Review Informed Consent Forms, CRFs, and study related materials
* Plan and participate in investigator meetings
* Assist and support data query process
* Assure regulatory compliance of investigational sites with the client's SOPs and FDA and ICH guidelines
* Ensures trial master file is current and maintained.
EXPERIENCE
* At least 3 years of experience in clinical trial management
* Experience in CNS and / or oncology is preferred
EDUCATION
* BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
QUALIFICATIONS
* Proven Management of people in a matrixed environment
* Management of global clinical trials
* Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
* Demonstrated ability to work independently and in a team environment
* Travel required. Must be willing to travel 15-25%, including international travel
* Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
* Excellent oral and written communication skills and strong organizational abilities
* Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
Description of Work Environment
* Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.
To be a best-fit your strengths must include:
* Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
* Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
* Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
* Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
* Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
* Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Experience
3+ years
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