We are currently searching for a skilled professional to join a well-known client's team as a Clinical Program Manager in King of Prussia, Pennsylvania. The Clinical Program Manager role will provide overall clinical project management, lead the cross-functional study execution team (SET), and coordinate study execution at the global level. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.RESPONSIBILITIES
- Plan, manage, and execute clinical programs
- Create, drive, and manage study-level timelines and budgets
- Develop overall feasibility concept and enrollment plan
- Provide input on operational aspects of the protocol and program strategy
- Ensure regulatory and GCP compliance
- Oversee the TMF with periodic audits
- Select and manage vendors, including issue escalation
- Build and implement Study Management plan and all associated documents
- Collaborate with team to plan and coordinate IMP and non-IMP supplies
- Lead and facilitate SET (internal) and vendor meetings
- Execute monitoring plan consistently in collaboration with COMs
- Address study issues in collaboration with SET and COMs
- Coordinate communications with external provider
- Arrange study specific training for Clinical Operations team and external provider
- Report key study performance information
- Facilitate study close out activities through completion of Clinical Study Report
- Act as the primary point of contact for internal groups for program/study specific information
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, regulatory considerations, and current medical/scientific/regulatory knowledge
- Verify standard processes, tools, and procedures are used consistently for study execution
- Minimum of 6 years of relevant clinical research experience within the pharmaceutical industry required
- Oncology liquid tumor experience
- Detailed understanding of the drug development process, specifically 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
- Excellent interpersonal and decision-making skills
- Experience with project management skills, including managing multiple projectssimultaneously
- Excellent planning, time management, and coordination skills
- Demonstrated ability to problem solve and comprehend complex scientific concepts and data
- Excellent written and oral communication skills
- Proficient computer literacy in appropriate software
To be a best-fit your strengths must include:
- Minimum of Bachelor's Degree in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area required
About Advanced Clinical
- 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.
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.