Associate Clinical Project Manager for Large Pharma client in Smyrna, GA

Are you interested in contributing to an outstanding, innovative, and collaborative team?  Our client, a Top Pharmaceutical Company committed to excellence and innovation in clinical research, is looking for an Associate Clinical Trial Manager to join their team in Smyrna, GA. Client is accepting candidates relocating from other areas of the U.S.Position Overview: The CPM may manage all or portions of a clinical study (e.g. initiation, conduct, analysis, and summarization) depending on the complexity or scope of the clinical study. With the support of their manager, the CPM may be responsible to lead the study team, to coordinate all activities needed to complete the essential study deliverables, study-specific operating guides and the trial master file until finalization of the clinical study report. The CPM may be responsible for managing the study in terms of time, resources, and budget to reach the study's objectives in a timely and cost efficient manner. Position is responsible for clinical phase timelines, individual study budgets and for decisions affecting the ultimate quality of the product.  Decisions made by CPMs can impact: Regulatory compliance, Data quality, Patient safety, and Investigator relations.Primary Responsibilities: Study document generation, including Informed Consent Forms, CRFs, Monitoring Guidelines, etc.  A CPM may also provide an in depth review of and contribution to study-specific documents from other functional areas (e.g. data cleaning plans, statistical analysis plans, vendor contracts, etc).  Cross-functional study team management, i.e., management of a matrixed team.  Study timeline management, with the support of their manager.  Vendor oversight, with the support of their manager, including selection, management and quality assurance, especially of monitoring and study management vendors, but also of other area vendors (e.g. central laboratories, IVRS, etc), in collaboration with O&C.  Study specific CRA training.  Identification, evaluation and selection of clinical investigators, together with CSM or through a vendor.  If the complexity/scope of the study permits, may initiate the project, i.e. creating the study team in agreement with line managers. The aim is to plan, conduct and report the study in the agreed time, quality, money and resource use. Therefore, and CPM may lead the clinical study team and manage the team members. The CPM will ensure adequate participation, contribution and accountability of the clinical study team members. The CPM has to define the area of responsibility delegated to the clinical study team members and ensure adherence to the relevant SOPs and PRIDE Processes.  Ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.  The CPM may be responsible for the budget management of a study.  Represent the clinical study team to clinical investigators, vendors, and consultants, together with their manager and the (Senior) Clinical Research Physician (Sr) CRP.  Share knowledge: The CPM is responsible for sharing the knowledge of the study with all appropriate parties, including Development Business Improvement Strategy Group (DBIS). The aim should be to make current studies more efficient and to make the "lessons learned" in current studies available for future studies. The CPM ensures regular debriefings, and searches for the appropriate expertise inside and outside of the clinical study team.  Willing to accept travel, possibly global.  Required Experience:  BS or BA degree, preferably with a scientific basis (e.g., Pre-medicine, Biology, Chemistry, Pharmacology, or Nursing)  At least 2-5 years of Clinical Development experience with a sponsor or CRO  Prior CRA management experience is expected, i.e., Senior/Lead/Coordinating CRA or Clinical Team Leader (as other companies use it in describing those who manage a CRA team).  Prior study management experience in the pharma or biotechnology arena is preferred.  Prior CNS experience is plus. Specific skills Demonstrates clear and articulate verbal, written and presentation skills with good command of the English language and the appropriate comportment to represent the client. Position is responsible for large portions of study conduct, and can include the entire clinical phase of a study.  Independent drive and follow through are required. Ability to comprehend medical content and data. Problem Solving   Must be able to independently identify and solve both data conflicts and situations representing lack of compliance to regulations and GCP in clinical trial conduct at clinical sites.  Must be able to comprehend and apply the correct prioritization to identified issues.  Exercises judgment within generally defined practices and policies, selecting methods and techniques for obtaining solutions. Normally receives general instruction on routine work, and detailed instruction on new assignments. If you are interested in this position, we invite you to please email a MS-Word copy of your resume to Cheryl Dapkus at cdapkus@smithhanley.com , or if you have any further questions please call 1-800-684-9921 Ext. 256.We look forward to hearing from you! Education:Bachelor's Degree Reference Code:3021160 Email:Apply by Email