Our client is looking for a Clinical Project Manager who will independently lead the study team in the development and execution of complex clinical trials. The ideal candidate will be accountable, globally, to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The CPM will consistently demonstrate leadership and influence when working with study teams, management, and business partners. The candidate will work with diverse teams to apply creative solutions to complex and key technical operational or business problems. This will include opportunities to work with vendors, affiliates/regions, global teams, and other business partners.
* Lead, influence and project manage large, complex studies and/or multiple smaller studies that deliver positive patient and investigator site experiences and quality data.
* Partner with other organizations to oversee and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
* Be accountable for enrollment strategy
* Accountability for trial documentation and ensuring inspection readiness of respective clinical trial(s) at all times. This includes timely documentation of deviations, creation of storyboards or issue summary documents (e.g. for high risk areas/hot topics) and coaches others CTPMs and study team in these activities.
* Lead vendor (including CRO) qualification process, selection, and oversight.
* Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Company standards of operation in the conduct of clinical trials.
* Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Laboratory Manual, Patient Diary, Study Reference binders, Pharmacy Manual, Clinical Data Review Plan, Clinical Database specifications development, Clinical Study Report (CSR) development, etc.
* Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate
* Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
* Conducts Sponsor quality monitoring/oversight visits to sites and/or CRAs performance assessment in adherence to GCP, corporate SOPs and protocol as needed.
* Creates, manages, measures, and reports timelines for milestone deliverables.
* Prepares metrics and updates for management.
* Utilize expertise to make timely decisions for ambiguous and complex situations. Uphold a consistent, solution-focused approach to conducting daily business.
* Recognize inter-relatedness of cross-study team activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across study teams and external partners and make decisions on process and issues affecting study implementation and execution.
* Network and apply expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver while reducing and/or mitigating risks.
* Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders.
* Contribute to the development of others by acting as a coach for peers as well as new CTPMs, study team members and business partners on aspects of CT process and regional specificities while maximizing shared learning.
* Identify and lead process improvement activities. Acts as an expert resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as the science allows.
* Utilize and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering customer needs.
This Position a fully In House opportunity, 5 days a week in the office.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.