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Senior Clinical Study Manager
King of Prussia, PA
Job Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Senior Clinical Study Manager in King of Prussia, Pennsylvania. This remote role will manage clinical operational planning activities, ensure on-time delivery of a clinical study (studies), and study execution of smaller, less-complex studies. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
EXPERIENCE
EDUCATION
To be a best-fit your strengths must include:
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality and 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 and 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 Senior Clinical Study Manager in King of Prussia, Pennsylvania. This remote role will manage clinical operational planning activities, ensure on-time delivery of a clinical study (studies), and study execution of smaller, less-complex studies. Your work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
- Create and drive study-level timeline
- Develop overall feasibility concept, enrollment plan, study budget, Study Management plan, and all associated documents
- Provide input on operational aspects of the protocol
- Ensure regulatory and GCP compliance
- Oversee the TMF with periodic audits
- Assist in vendor selection and management including issue escalation
- Collaborate with team to plan and coordinate IMP and non-IMP supplies
- Plan, facilitate, and lead SET internal meetings
- Verify monitoring plan is developed and consistently executed
- Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and Clinical Oversight Managers (COMs)
- Assign and document study-specific roles/responsibilities to internal/external team members
- Consult with COMs for strategic selection of countries and sites
- Facilitate/coordinate communications with external provider and study close-out activities through completion of Clinical Study Report
- Confirm Clinical Operations team and external partners receive study specific training
- Report key study-performance information (study start-up metrics, enrollment, data collection timeliness/quality, etc.)
- Act as the primary point of contact for study specific information
- Maintain current knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
- Ensure standard processes, tools, and procedures are used consistently for study execution
EXPERIENCE
- Minimum of 6 years of relevant clinical research (or related) experience within the pharmaceutical industry required
- Strong understanding of the drug development process, including each step within the clinical trial process
- Experience overseeing global clinical trials (pharmaceutical or research institute) required
- Budget forecasting and management experience
- Detailed knowledge of ICH guidelines/GCP and how it applies to all stages of the clinical development process
- Experience in scientific/medical research desired
- Specialist knowledge (immunology, coagulation disorders, pulmonology, virology, oncology, and cardiology) desired
- Demonstrated ability to lead teams and work in a fast-paced team environment
- Excellent interpersonal, planning, and decision-making skills
- Good understanding of all tasks involved in a clinical development program
- Demonstrated ability to comprehend complex scientific concepts and data
- Proficient in reviewing and assessing clinical data
- Excellent written and oral communication skills
- Travel required (domestic and international travel) - up to 5%
EDUCATION
- Minimum of Bachelor's Degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area required
- Postgraduate qualifications desired
- Other degrees and certifications (diploma or associate degree RN, certified medical technologist) considered if combined with related clinical research experience
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. Thorough 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 and 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 and 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 Education
Associate Degree
Required Experience
6+ years
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