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Clinical Project Manager

JNE Research Inc


Location:
Cambridge, Massachusetts
Date:
03/29/2017
Job Type:
Employee
Job Status:
Full Time
Categories:
  • Clinical Operations
JNE Research Inc
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  • Research Salary

Job Details

Company: Global Pharma Company ( IPSEN )

Location: Cambridge, MA (Flexibility to work from home few days a week)

Job description:

Oversee and drive all aspects of the assigned global international clinical study(ies) in respect of planning/timelines, quality, budget and defined goals.

Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to Clinical Study Report.

Ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines and SOPs in the required standard of quality.

Drive execution – including CRO/vendor activities - report activities and highlight issues to facilitate decision making in conjunction with Clinical Development Program Directors (CDPDs), Medical Dev. Directors (MDDs), and other Company team members as appropriate.

Manage and lead the cross-functional Clinical Study Team and Contract Research Organization (CRO)s/vendors in collaboration with the CDPDs and the other Company study team members (CRA Lead, CTA, MDD, CDPM, Stat, GPS rep, Finance controller, CMC…)

Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Company clinical study team members and CROs.

Requirements

Company: Global Pharma Company ( IPSEN )

Location: Cambridge, MA (Flexibility to work from home few days a week)

Job description:

Oversee and drive all aspects of the assigned global international clinical study(ies) in respect of planning/timelines, quality, budget and defined goals.

Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to Clinical Study Report.

Ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines and SOPs in the required standard of quality.

Drive execution – including CRO/vendor activities - report activities and highlight issues to facilitate decision making in conjunction with Clinical Development Program Directors (CDPDs), Medical Dev. Directors (MDDs), and other Company team members as appropriate.

Manage and lead the cross-functional Clinical Study Team and Contract Research Organization (CRO)s/vendors in collaboration with the CDPDs and the other Company study team members (CRA Lead, CTA, MDD, CDPM, Stat, GPS rep, Finance controller, CMC…)

Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Company clinical study team members and CROs.

______________________________________________________________________________

Job Responsibilites: (Manage, and Execute Assigned Projects)

§ Set-up and lead study teams

§ Contribute to study protocol development including study concept where applicable

§ Propose and control planning and study timelines in collaboration with all other Company supportive functions/CRO

§ Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider/CRO

§ Participate in the selection of Services Providers /CROs and other external vendors in collaboration with purchasing department, study team and Corporate Legal Affairs

§ Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports

§ Ensure appropriate oversight of Services Providers /CRO(s) and other external vendors activities and develop the study oversight manual in collaboration with the other study team members

§ Review final draft and approve major study documents as described in the Services Providers /CROs plans (e.g. oversight manual, communication plan, project plan, instruction manuals….)

§ Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, CRO and Company Affiliates (if needed) to identify and gain approval for high quality investigators and study sites

§ Support the CTA assigned to the study for: insurance certificate, contracts signature process, set-up, update and archive of the Trial Master File (TMF/eTMF), transparency and local requirements reporting as per legal and Company requirements, update of reporting tools (study trackers, Hermes,…) and alert if required; drive billing and forecast§ Work with the CRO to develop and approve a recruitment strategy and communication tools (e.g. Newsletter…) to increase study awareness, patient recruitment and retention in the study

§ Ensure through study team management that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities in conjunction with the Regulatory, Pharmacovigilance (GPS), Data Management and Statistics Departments

§ Participate in meetings lead by CRO (e.g. Inv. & CRA meeting, Clinical Data Review …), internal meeting - Review meeting minutes and ensure with CRO Project Manager that issues are proactively identified, communicated and resolved in a timely manner

§ Ensure timely and accurate completion of project milestones, study progress tools (planning reporting, study dashboard...) and escalate appropriately in case of deviation to the planning and of any issue regarding the quality of the data

§ Travel as needed to observe and discuss projects, build positive working relationships and maintain enthusiasm regarding projects

§ For activities not out-sourced (e.g. Management of IMP…) ensure regular forecast update and bulk shipment

§ Work with line functions and Quality Assurance (GRDQ) to identify potential quality issues. Coordinate post quality audit hosted by Sponsor and ensure CAPA implementation by CRO

§ May assist Quality Assurance (GDDQ) within inspections preparation as applicable

§ Participate in the preparation and review of clinical study reports. Liaise with the relevant Ipsen or Service Providers/CRO teams to ensure the posting of clinical study results on the required registries and as per local regulations.

______________________________________________________________________________

- A minimum of 5 years working in Clinical Research with a minimum of 3 year experience as Clinical Project Manager in PhI-III trials

- Experience in international clinical development trials (PhI to PhIII)

- Experience in Oncology

- Experience in working with CROs

- Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.