Senior Manager Clinical Research at Pharmaceutical Company in NJ, New Jersey, United States —
- Pharmaceutical Company
- NJ, New Jersey, United States USA
- 2/22/21 2021-02-22
Job ID: 20210208
Job purpose This person is responsible for leading the clinical research activities for a specific program or programs as well as managing all activities associated with performing a clinical trial. This person has the responsibility to guide and supervise clinical research activities performed by consultant monitors (when applicable) and clinical trial assistant working on assigned projects. Essential Activities, Duties, Tasks and Responsibilities Writing and finalizing protocols for the conduct of interventional clinical trials and non-interventional trials as well as studies designed for the retrospective collection of data. Identifying, selecting and qualifying sites to conduct clinical trials. Reviewing informed consent forms and other Trial Master File (TMF) documents, ensuring that all regulatory requirements are met. Performing site visits including monitoring activities as needed/assigned, insuring the clinical trial is being performed according to ICH/GCP guidelines and meeting the protocol requirements. Planning, coordinating, and facilitating investigator meetings. Communicating with study centers, addressing issues and disseminating study trial information. Training investigators, monitors and site personnel to ensure appropriate collection and reporting of non-serious and serious adverse events, as well as special situations, and any urgent safety measures taken by the site during the study. Assisting with data flow and query resolution. Requesting and managing clinical supplies, including coordinating the shipment of the clinical supplies to study sites, over-seeing drug accountability and the return of clinical supplies to. Managing vendors and consultants (e.g., central ECG and central lab services). Insuring that all project information is up to date in the Clinical Trial Management System (CTMS) (e.g. monitoring visits; enrollment). Tracking enrollment for each site; proactively addressing issues, insuring protocol compliance. Creating and maintaining the TMF Initiating payments to investigators Overseeing payments to vendors: reviewing invoices including documentation supporting pass through costs Overseeing the tracking of receipt of original CRFs in house. Submitting SUSARs to IRBs/ECs and Investigators as needed. Ensuring that projects keep within their approved budget. Communicating critical study-related or personnel issues to the Head of Worldwide Clinical Research in a timely manner to facilitate immediate action. Secondary Activities, Duties, Tasks and Responsibilities Reviewing and commenting on documents circulated by other functions within GM&RA (e.g., Investigators Brochures; Tables Listings Figures; Data Review Conventions; Clinical Study Reports). Providing input to the Head of Worldwide Clinical Research budget estimations and re-forecasts when required. Supervisory Responsibilities NA Professional Experience 3+ years Clinical Research/Management experience with demonstrated experience in multinational and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines. Strong organizational, communication and team work skills. Ability to manage several projects simultaneously. Desired: Experience in diagnostic imaging field.
Supervisory Responsibilities NA Professional Experience 3+ years Clinical Research/Management experience with demonstrated experience in multinational and/or multi-site clinical studies. Knowledge of GCPs, CFR, ICH and EU guidelines. Strong organizational, communication and team work skills. Ability to manage several projects simultaneously. Desired: Experience in diagnostic imaging field
Professional knowledge The requirements listed below are representative of the core competencies. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Significant experience in Clinical Research Ability to manage multiple projects/programs simultaneously Ability to manage investigators, consultants, vendors Excellent written and verbal communication skills with particular attention to communicating study information Taking personal responsibility to achieve results/objectives and makes every effort to achieve the expected outcome of any task. Ability to work independently, with minimum supervision. Ability to work in team Ability to deal with competing priorities, meet aggressive timelines within the assigned budget Core Relationships Medical Planning and Management Medical Biometrics Regulatory Affairs Corporate Drug Safety Medical Writing Management Services Corporate Quality Management Clinical Research Quality Systems. Legal Department Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Travel: Up to 20% Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.