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Clinical Trial Operations Manager III
Ref No.: 16-00404
Location: Cambridge, Massachusetts
There are 3 positions available. Manager wants at least 2 of these to sit in Cambridge, but they are open to the possibility hiring 2 for Cambridge and one for Bridgewater NJ.   

The CTOM is responsible for the overall operational planning and activities for the implementation and conduct of studies (clinical trials, observational studies, compassionate use and registries) including data management activities in compliance with GCP's, SOPs and standards within established timelines and budgets.
The CTOM is involved in the scientific conduct of the study and acts as the leader of operational disciplines to guarantee release of homogeneous high quality data, in close collaboration with other CSO department representatives (e.g. Medical Operations) May be required to take-on the Dedicated Project Expert (DPE) role depending on CTOM's level of experience, relevant skill-set and business needs.
Major Duties and Responsibilities:
  1. Provide oversight of a study to ensure progress according to study timelines
    • Lead the clinical trial team (CTT) (including representatives from CSUs/affiliates/CROs, GPE, Medical Operation, Biostatistics, Clinical Supplies Platform, Regulatory, Pharmacokinetics and other relevant departments) for the operational aspects of the study.  Liaise with the feasibility manager to review and assess country feasibility. Liaise with clinical purchasing to prepare the RFP (request for proposal), review vendors' specifications and oversee vendor activities and deliverables (i.e., Central Lab, IVRS, data management, monitoring Meeting Planner). Liaise with coding and TIM representatives when applicable.
  2. Ensure proper documentation/availability
    • Contribute to the extended synopsis, protocol, amendments, and WSI (operational sections) development and review to ensure operational feasibility; Definition of the Case Report Form content and testing of the end product.
    • Develop study-specific procedures and write the Monitoring Plan, the Data Management Plan, the Data Validation Plan, the Case Report Forms (including testing) and completion guidelines, the Data Review & Surveillance Plan and/or other operational documents in conjunction with the CTT.  Review other CTT and vendor-developed or co-developed documents (e.g., specifications, scope of work, operational manuals, communication plans, retention and recruitment plans, data transfer plans, etc.) as requested to provide operational input (including on-time and high quality).
    • Ensure appropriate testing/UAT are performed as required (e.g. eCRF screens, database structure, data loading, etc)
    • Ensure that clinical and data management standards are followed for the study.
  3. Ensure proper collection and validation of data and documentation on a timely manner
    • Assure proper overview and communicate to teams (including on-time and high quality) of monitoring activities, data flow, data validation and when applicable, coordinates the centralized review of procedures.
    • Perform patient data validation homogeneously and fulfilling required quality standard.
    • Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-rooms and databases as required.
  4. Organize study specific meetings (CTT excluded)
    • Coordinate and support field-monitoring activities through regular meetings: teleconferences and/or visits to CSU's, training of monitoring teams, investigator meetings. CRO management if applicable.
    • Prepare and lead data review meeting, organize and contribute to medical review meetings.
  5. Collect, synthesize and report study information
    • Maintain and provide information for monthly study highlights (including enrollment curves and timelines) on a timely manner
  6. Investigational Product (IP) Management
    • Collaborate with the CSP to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process.
  7. Participate in the development/follow-up of the study budget and selection and management of vendors
    • Define needs, tasks and responsibilities of external vendors, review contracts, estimate costs of logistical aspects of the study and ensure tracking payments for operational aspects of the study are done, in collaboration with the Clinical Purchasing department
  8. Preparation and oversight of study audits/inspections both internal and external
    • Ensure preparation and proper responses to audit/inspection reports & consolidation of findings and communicate important observations to CTT and/or DPE and Team Leader.
    • Develop and implement immediate action plan at global CSU/sites level if needed
  9. Provide oversight and preparation for FDA pre-approval inspections (PAI)
    • Upon request, prepare and assist in PAI preparation plan with the PAI project team.
    • Utilize designated tools developed to oversee quality (e.g. Polaris BO reports, etc) for an Inspection-readiness approach and to prepare for CSU CTTs & DRS meetings to optimize monitoring efficiency & quality
  10. Mentors/trains new comers
    • Participate, as a delegate to TL, to the training of new CTOMs on therapeutic area and general responsibilities within their function
  11. Dedicated Project Expert (DPE) role:
    • The Dedicated Project Expert (DPE) is a role performed by a senior Clinical Trial Manager (CTM), senior Study Data Manager (SDM) or senior Clinical Trial Operations Manager (CTOM) in addition to his/her direct study responsibilities; direct study responsibilities may be adjusted depending on the coordination activities workload of the designated clinical program.
    • The DPE is accountable for operational oversight of the clinical program conducted within Trial Operations. He/she coordinates with CTM(s), SDM(s) and CTOM(s) working on the designated program to ensure operational consistency, to identify possible synergies, and to ensure that the team works closely together to meet the program goals on time and with good quality.
    • The DPE assists the CSO CSP Project Leader (PL) in developing/ following the execution of the program operational statement. The DPE is the primary point of contact for PL within TO and will represent CTMs/SDMs/CTOMs working on program as the designated CSO CSP Project Team Member. He/she is the primary responsible person for escalation of program issues/information within Trial Operations and will ensure that PL and TL are being provided with regular reporting on the program progress.
    • The DPE provides input to help TL ensure alignment according to risk adjustment and study milestones.
Skills: Knowledge & Skills:
Capable of interacting effectively with scientists and managers within and outside CSO SCP; serve as internal consultant on assigned area and liaise with external organizations on projects.
Strong interpersonal and communication skills (verbal and written) Ability to handle multiple task and to prioritize, strong organizational and presentation skills Leadership skills Project Management skills Decision-making and problem-solving skills Ability to work autonomously and to efficiently & effectively provide status reports Ability to anticipate and timely escalate issues and to define appropriate action plans Good cross-functional team leader who fosters team spirit and team motivation (team work) Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc) Ability to work in an international environment with internal and/or external partners (CROs etc) Strong verbal and written English skills Ability to adapt and be flexible to change and managing internal and external impediments Understanding of data base concepts preferred Knowledge or ability to rapidly gain knowledge with programming/query languages Knowledge of industry data management standards and practices Must be able to interact effectively with a variety of internal and external teams CTOM will consult with the DPE/PL to ensure study decisions are aligned on program timelines, strategy and budget
Bachelor's degree (advanced degree preferred) plus at least 7 years of experience in pharmaceutical industry or clinical-related discipline including at least 5 years clinical research experience, including 2 years of trial operations management.