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Senior Clinical Project Manager 7/27/2018

Emergent BioSolutions Gaithersburg, MD

Location
Gaithersburg, MD
AJE Ref #
582384450
Job Classification
Full Time
Job Type
Regular
Company Ref #
25701
Experience
Mid-Career (2 - 15 years)
Education
Bachelors Degree

JOB DESCRIPTION

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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Senior Clinical Project Manager (Sr. CPM) will lead the project team in the planning, implementation and management of the day-to-day operations of the clinical studies to meet overall project objectives while ensuring compliance with Good Clinical Practice, SOPs and other applicable regulations. Sr. CPM will collaborate with all members of the clinical department and other functions for improvement of standard processes. The Sr. CPM may also be assigned to collaborate/lead department s responsibilities in proposal generation to funding agencies, participate in strategic development of clinical programs, and supervise direct reports.

Responsibilites

Proposal, Contracting and Funding:

* Leads development of outsourcing model to be utilized for clinical studies.

* Generates statements of work (SOW), request for proposals (RFPs) process.

* Identifies potential vendors to participate in clinical trials, develops evaluation tools, and leads selection of service providers by working with internal subject matters for the evaluation and selection of external vendors including but not limited to CROs, central laboratories, drug depots, and consultants.

* For government funded studies collaborate with government contracts group and external vendors to negotiate contract terms and budget for projects.

* For internally funded programs, authors the RFP documents and leads the RFP process from issuance of the RFP to the receipt of proposals and selection of vendors. For internally funded programs, finalizes SOW and negotiates and facilitates contract execution with relevant service providers/clinical trial sites by interfacing with external contacts and internal Legal/Financial departments.

* Works within the Company s contract software program or liaises with internal SMEs to add new suppliers and to initiate routing of, but not limited to, contracts, task orders and change orders.

* Tracks budget versus actual for all vendors within a project in collaboration with Project Management.

Project planning, conduct, and closeout:

* Creates realistic, achievable timelines for proposed projects, providing a project management framework for planning and executing clinical trials.

* Writes/oversees/collaborates with other delegates for creation of key study documents: protocols, investigational brochures, consent forms, clinical study reports, project management plan, case report forms, and other related clinical documents for implementation of clinical program.

* Writes/oversees the Contract Research Organization in generation of clinical documents and study manuals: monitoring plan, pharmacy manual, laboratory manual, site instructions, and all study specific procedures.

* Per SOP, manages and requests all investigation product needs for clinical study.

* Oversees/coordinates investigator and study meetings, including preparation and presentation of information and training investigative site staff on protocol, study conduct, regulatory requirements and GCP.

* As required, develops project tools to track study progress, site enrolment, monitoring, and other clinical study metrics, including completeness of documentation and data collection, management of investigational product, and study supplies.

* Interacts with internal groups including clinical science, data management and biostatistics, pharmacovigilance, shipping/logistics, regulatory affairs, quality assurance and project management during clinical study lifecycle to assure efficient administration of project requirements.

* Oversees management of clinical study sites to ensure adherence to regulatory requirements and GCP, including identification, evaluation, selection, start-up activities, initiation, routine on-site monitoring and closeout visits (eg. IRB submission, central / local labs, subject e-diaries, IVRS, e-TMF).

* Liaises with Quality Assurance to ensure appropriate auditing of service providers and clinical study sites.

* As required, assists in preparation of documents required for regulatory submissions and interface with internal team to ensure timely completion.

* Provides oversight to all external vendors associated with clinical study, including tracking of milestones and deliverables, review of reports, administration of payments and contract administration (includes large contracts, multiple vendors for clinical program).

* Accountable for tracking and management of overall clinical study budgets, including clinical site budgets and budgets of relevant service providers.

* Acts as lead clinical representative at regulatory inspections.

* Identifies and implements effective risk mitigation strategy.

* Amends timelines as the project dictates or as the company priorities change.

* Collaborates with internal project management team/senior management to provide corporate project updates on clinical study/clinical program progress.

* Oversees the CRO during investigator site close out and confirms acceptability of all remaining project deliverables.

* Collaborates with the Medical Monitor, Clinical Scientist, Medical Writer, Statisticians, and Data Management on the review and analysis of study data.

* Reviews Tables, Listings, Graphs and Figures and draft clinical study reports.

* Collaborates with Medical Writing and Biostatistics for writing of the Clinical Study Report (CSR) eg. generation of report appendices or authorship of relevant sections of the CSR, or if outsourced, oversees the vendor and provide feedback from the Emergent team.

* Development of Departmental Infrastructure

* Develops/revises departmental project tools to track study progress, site enrolment, monitoring, and other clinical trial metrics, including completeness of documentation and data collection, management of investigational product, and study supplies

* Develops team workflows with internal groups including clinical science, data management and biostatistics, pharmacovigilance, shipping/logistics, regulatory affairs, quality assurance and project management during clinical study lifecycles to assure efficient administration of project requirements and ensure process support.

* Develops and updates SOPs as required to ensure continued compliance with ICH-GCP, regulatory updates.

* Leadership:

* Leads multiple complex projects/clinical studies at various stages of development and provides progress reporting to senior/executive management

* Aid Clinical Director in development and prioritization of measurable short and long term goals for clinical study programs.

* Build strategic partnerships/networking relationships with consultants and potential outsource providers for clinical development programs

* Mentors and provides training for clinical project managers, project specialists and clinical study administrators as appropriate. If required by organizational need, may provide direct line management to other Clinical Operations staff.

* Manages the Clinical sub-team for large projects encompassing more than one Clinical Project Manager and Clinical Project Specialist.

* Collaborates working across the subsidiaries of Emergent.

* May act as the backup for Director of Clinical Operations.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.