Job title: Clinical Program Manager
Company: Advanced Clinical
Job description: OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team in King of Prussia, Pennsylvania as a Clinical Program Manager (CPM) in King of Prussia, Pennsylvania. This remote CPM role will manage all clinical operational planning activities and lead program/study execution. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
- Plan, manage, and execute clinical programs
- Create and drive study-level timeline
- Develop and manage study budget
- Provide input on operational aspects of the protocol
- Ensure regulatory compliance and GCP compliance
- Oversee the TMF with periodic audits
- Lead vendor selection and management, including issue escalation
- Establish and implement Study Management plan and all associated documents
- Collaborate with team to plan and coordinate IMP and non-IMP supplies
- Plan, lead, and facilitate internal meetings and act as the company lead for vendor meetings
- Ensure monitoring plan is developed and consistently executed in collaboration with COMs
- Consult with COMs for strategic selection of countries and sites
- Coordinate communications with external provider, including study specific training
- Report key study performance information
- Facilitate study close-out activities through completion of Clinical Study Report
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations
- Utilize standard processes, tools, and procedures for study execution
- Minimum of 6 years of relevant clinical research experience within the pharmaceutical industry required
- Detailed understanding of each step within the clinical trial process
- Experience overseeing global clinical trials (pharmaceutical or research institute)
- Budget forecasting and management experience
- Detailed knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical process
- Experience in scientific/medical research desired
- Proficient in MS Project
- Strong interpersonal and decision-making skills
- 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
- Ability to comprehend complex scientific concepts and data
- Demonstrated project management skills
- Excellent planning, time management, and 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
- Minimum of Bachelor’s Degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area required
- Other degrees and certifications considered if commensurate 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 & 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.
Location: King of Prussia, PA
Job date: Tue, 16 Nov 2021 23:02:29 GMT
Apply for the job now!